Performance and Safety of the ANTALGEEK® Thess Monitoring Medical Device in the Outpatient Management of Acute Pain and Postoperative Recovery (TRACE)
6 luglio 2026 aggiornato da: Centre Hospitalier Universitaire de Nīmes
Evaluation of the Performance and Safety of the ANTALGEEK® Thess Monitoring Medical Device in the Outpatient Management of Acute Pain and Postoperative Recovery - A Single-Center, Randomized, Controlled Proof-of-Concept Study.
Acute postoperative pain (APOP) is a major public health problem, affecting nearly 10 million patients in France each year.
Effective analgesic therapy in the first postoperative week is a key factor in reducing early postoperative morbidity and mortality.
Poorly controlled APOP is a major risk factor for chronic postoperative pain.
In France today, more and more patients undergo surgical procedures as outpatients.
The challenge is to manage postoperative pain in the homes of patients who have undergone increasingly complex surgical procedures, either after outpatient surgery or after a prompt return home as part of an Enhanced Recovery After Surgery (ERAS) protocol.
In outpatient surgery, postoperative pain management requires new strategies and/or organizational approaches to ensure high-quality pain management from the very start.
The principle of analgesia for acute postoperative pain recommends: i) routine, fixed-schedule maintenance therapy; and ii) rescue therapy if maintenance therapy is insufficient, based on pain titration, using mild or strong oral opioids.
Postoperative pain is the primary focus of postoperative care but the goal is also to improve postoperative recovery and enhance the patient's overall care.
To date, there are no medical telemonitoring devices to support the patient in properly taking their analgesics based on multiple-daily assessments of the efficacy and tolerability of the analgesic treatment, enabling systematic postoperative screening for early and late warning signs of the risk of chronic pain.
The Thess Monitoring device, which implements the ANTALGEEK® protocol, (TMA) was developed to optimize the efficiency of outpatient management of acute postoperative pain.
It improves patients' adherence to maintenance treatment with adaptive, personalized control of analgesia through better use of opioid rescue therapy, and the reduction of adverse effects associated with improper opioid use (under- or over-dosing).
The aim is to ensure optimal pain resolution and improve early and late postoperative recovery during the first postoperative week.
The TMA system enables remote monitoring of the efficacy and tolerability of analgesic treatment, as well as early and late warning signs of the risk of chronic pain.
By measuring pain scores daily during the first postoperative week, it identifies patients with a suboptimal pain trajectory who are at high risk of developing persistent pain beyond the third month.
It also assesses warning signs of the risk of chronic pain (neuropathic pain, persistent opioid use) at intervals following the procedure (Day 8, Month 1, Month 2, Month 3).
Improving the patient care pathway via the TMA system should make it possible to better coordinate postoperative follow-up between hospital-based and community-based care.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Descrizione dettagliata
The problem of acute postoperative pain (APOP) is a major public health problem, affecting nearly 10 million patients in France each year and potentially leading to numerous complications when inadequately managed. In the postoperative period, the implementation of effective analgesic therapy is a key factor in reducing early postoperative morbidity and mortality. Furthermore, poorly controlled PPS is one of the major risk factors for the development of chronic postoperative pain (CPOP). Optimizing analgesic medication to prevent an abnormal pain trajectory during the first postoperative week is a key strategy for preventing chronic postoperative pain.
Today, within the French healthcare system, an increasing number of patients undergo surgical procedures performed on an outpatient basis. The big challenge is to manage postoperative pain in the homes of patients who have undergone increasingly complex surgical procedures, either following outpatient surgery or after an early return home as part of an Enhanced Recovery After Surgery (ERAS) protocol.
In outpatient surgery, improving postoperative pain management requires the implementation of new strategies and/or organizational approaches to ensure a high-quality pain management pathway from the very beginning.
The principle of analgesia for acute postoperative pain recommends a combination of: i) routine, fixed-schedule maintenance therapy; and ii) rescue therapy-if maintenance therapy is insufficient-based on the principle of pain titration, using oral opioids (mild or strong). While postoperative pain remains the primary focus of postoperative care, the goal is also to improve postoperative recovery more broadly and thereby enhance the patient's overall care.
The assessment of postoperative recovery in outpatient surgery patients using a medical telemonitoring device is associated with a reduction in discomfort caused by various postoperative symptoms, including postoperative pain. However, to date, there is no medical telemonitoring device that both supports the patient in properly taking their analgesics based on multiple-daily assessments of the efficacy and tolerability of the analgesic treatment, and enables systematic postoperative screening for early and late warning signs of the risk of chronic pain.
To this end, the Thess Monitoring medical telemonitoring device (which implements the ANTALGEEK® protocol) (TMA) was developed. It is a tool for continuous therapeutic support and postoperative telemonitoring designed to optimize the efficiency of outpatient management of acute postoperative pain in patients by improving adherence to maintenance therapy, adaptive and personalized control of analgesia through better use of opioid rescue therapy, and the reduction of adverse effects associated with improper opioid use (under- or over-dosing), with the goal of ensuring optimal pain resolution and improved early and late postoperative recovery during the first postoperative week (Baseline-Day 7). To achieve this, the TMA system enables remote monitoring of the efficacy and tolerability of analgesic treatment, as well as early and late warning signs of the risk of chronic pain: identify, through daily measurement of pain scores during the first postoperative week, patients with a suboptimal pain trajectory who are at high risk of developing persistent postoperative pain beyond the third month; assess warning signs of the risk of chronic pain (neuropathic pain, persistent opioid use) at intervals following the procedure (Day 8, Month 1, Month 2, Month 3).
Improving the patient care pathway through the TMA system should thus make it possible to better coordinate postoperative follow-up between hospital-based and community-based care.
In this initial proof-of-concept study, the investigators aim to evaluate the performance and safety of the TMA medical device in the outpatient management of acute pain during the first postoperative week, as well as its impact on postoperative recovery and on reducing the risk of pain becoming chronic by the third postoperative month.
Tipo di studio
Interventistico
Iscrizione (Stimato)
150
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Anissa MEGZARI
- Numero di telefono: 0466684236
- Email: drc@chu-nimes.fr
Backup dei contatti dello studio
- Nome: Joël LHERMITE, Dr.
- Numero di telefono: +334.66.68.30.50
- Email: joel.lhermite@chu-nimes.fr
Luoghi di studio
-
-
Gard
-
Nîmes, Gard, Francia, 30029
- Reclutamento
- Nîmes University Hospital
-
Contatto:
- Anissa MEGZARI
- Numero di telefono: +33466684236
- Email: drc@chu-nimes.fr
-
Contatto:
- Nimes U Hospital, Dr.
- Numero di telefono: +334.66.68.30.50
- Email: joel.lhermite@chu-nimes.fr
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Patients eligible for outpatient surgery.
- Patients undergoing surgery likely to result in moderate to severe pain.
- Patients available for a 3-month follow-up.
- Patients who have provided their free and informed consent.
- Patients who have signed the consent form.
- Patients enrolled in or covered by a health insurance plan.
Exclusion Criteria:
- Patients participating in an interventional RIPH study involving a drug or classified as Category 1.
- Patients in an exclusion period determined by another study.
- Patients under judicial protection, guardianship, or conservatorship.
- Patients unable to express consent.
- Patient for whom it is impossible to provide informed information.
- Pregnant, laboring, or breastfeeding patients.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: Postoperative pain management : standard care
Patients receiving standard postoperative analgesic care
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Sperimentale: Postoperative pain management using the Thess telemonitoring device
Patients being monitored with the Thess Monitoring medical telemonitoring device in conjunction with the ANTALGEEK® protocol
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The Thess monitoring medical device (Thess Corp., Montpellier) uses the remote ANTALGEEK® telemonitoring protocol to manage pain in outpatients who have had surgery causing moderate-to-severe pain.
It digitalizes and optimizes acute postoperative pain management at home by improving adherence to maintenance therapy, with adaptive, tailored control of analgesia through better use of opioid rescue therapy to reduce the adverse effects of opioid misuse and ensures optimal pain resolution and postoperative recovery during the first week.
The ANTALGEEK decision-making algorithm and a medical telemonitoring protocol help patients follow their pain medication regimen, monitoring them in postoperative Week 1, based on the preoperative prescription, data on the patient's adherence to treatment, its efficacy and tolerability.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Performance of the TMA® medical device (TMA group) according to the QoR-15 questionnaire score in the experimental group
Lasso di tempo: Day 2
|
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being.
The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient).
Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome).
The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery).
Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
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Day 2
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Performance of the TMA® medical device (TMA group) according to the QoR-15 questionnaire score in the standard care (control) group.
Lasso di tempo: Day 2
|
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being.
The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient).
Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome).
The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery).
Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
|
Day 2
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group
Lasso di tempo: Day 1, before the intervention
|
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being.
The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient).
Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome).
The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery).
Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
|
Day 1, before the intervention
|
|
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group
Lasso di tempo: Day 1, after the intervention
|
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being.
The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient).
Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome).
The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery).
Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
|
Day 1, after the intervention
|
|
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the experimental group
Lasso di tempo: Day 7
|
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being.
The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient).
Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome).
The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery).
Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
|
Day 7
|
|
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group
Lasso di tempo: Day 1, before the intervention
|
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being.
The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient).
Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome).
The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery).
Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
|
Day 1, before the intervention
|
|
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group
Lasso di tempo: Day 1, after the intervention
|
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being.
The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient).
Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome).
The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery).
Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
|
Day 1, after the intervention
|
|
Quality of postoperative recovery (QoR15) during the early and late phases of recovery in the standard care (control) group
Lasso di tempo: Day 7
|
The QoR-15 (quality of recovery) questionnaire comprises 15 items assessing different aspects of a patient's recovery : symptoms, functional status, and emotional well-being.
The 15 items are grouped into five domains: Physical Comfort (symptoms like nausea, vomiting, and general discomfort), Emotional State (feelings such as anxiety, depression, or general well-being), Physical Independence (the patient's ability to look after themselves, such as mobility and self-care), Psychological Support (feelings of support and reassurance) Pain (the level of pain experienced by the patient).
Each item in the QoR-15 is scored on an 11-point numerical scale ranging from 0 (none of the time/worst outcome) to 10 (all of the time/best outcome).
The sum of the scores for each of the 15 items results in a score ranging from 0 (very poor recovery) to 150 (excellent quality of recovery).
Excellent: QoR-15 score > 135, Good: QoR-15 score between 122 and 135 (inclusive), Moderate: QoR-15 score between 90
|
Day 7
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Pain progression in the experimental group
Lasso di tempo: Day 1
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
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Day 1
|
|
Pain progression in the experimental group
Lasso di tempo: Day 2
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Day 2
|
|
Pain progression in the experimental group
Lasso di tempo: Day 3
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Day 3
|
|
Pain progression in the experimental group
Lasso di tempo: Day 4
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Day 4
|
|
Pain progression in the experimental group
Lasso di tempo: Day 5
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Day 5
|
|
Pain progression in the experimental group
Lasso di tempo: Day 6
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Day 6
|
|
Pain progression in the experimental group
Lasso di tempo: Day 7
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Day 7
|
|
Pain progression in the experimental group
Lasso di tempo: Month 1
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Month 1
|
|
Pain progression in the experimental group
Lasso di tempo: Month 2
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Month 2
|
|
Pain progression in the experimental group
Lasso di tempo: Month 3
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Month 3
|
|
Pain progression in the in the standard care (control) group
Lasso di tempo: Day 1
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Day 1
|
|
Pain progression in the in the standard care (control) group
Lasso di tempo: Day 2
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Day 2
|
|
Pain progression in the in the standard care (control) group
Lasso di tempo: Day 3
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Day 3
|
|
Pain progression in the in the standard care (control) group
Lasso di tempo: Day 4
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Day 4
|
|
Pain progression in the in the standard care (control) group
Lasso di tempo: Day 5
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Day 5
|
|
Pain progression in the in the standard care (control) group
Lasso di tempo: Day 6
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Day 6
|
|
Pain progression in the in the standard care (control) group
Lasso di tempo: Day 7
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Day 7
|
|
Pain progression in the in the standard care (control) group
Lasso di tempo: Month 1
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Month 1
|
|
Pain progression in the in the standard care (control) group
Lasso di tempo: Month 2
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Month 2
|
|
Pain progression in the in the standard care (control) group
Lasso di tempo: Month 3
|
Average pain score over 24 hours according to the Visual Analog Scale (0 -10)
|
Month 3
|
|
Incidence of adverse effects associated with opioid use in the experimental group
Lasso di tempo: Day 1
|
Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
|
Day 1
|
|
Incidence of adverse effects associated with opioid use in the standard care (control) group
Lasso di tempo: Day 1
|
Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
|
Day 1
|
|
Incidence of adverse effects associated with opioid use in the experimental group
Lasso di tempo: Day 2
|
Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
|
Day 2
|
|
Incidence of adverse effects associated with opioid use in the standard care (control) group
Lasso di tempo: Day 2
|
Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
|
Day 2
|
|
Incidence of adverse effects associated with opioid use in the experimental group
Lasso di tempo: Day 3
|
Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
|
Day 3
|
|
Incidence of adverse effects associated with opioid use in the standard care (control) group
Lasso di tempo: Day 3
|
Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
|
Day 3
|
|
Incidence of adverse effects associated with opioid use in the experimental group
Lasso di tempo: Day 4
|
Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
|
Day 4
|
|
Incidence of adverse effects associated with opioid use in the standard care (control) group
Lasso di tempo: Day 4
|
Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
|
Day 4
|
|
Incidence of adverse effects associated with opioid use in the experimental group
Lasso di tempo: Day 5
|
Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
|
Day 5
|
|
Incidence of adverse effects associated with opioid use in the standard care (control) group
Lasso di tempo: Day 5
|
Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
|
Day 5
|
|
Incidence of adverse effects associated with opioid use in the experimental group
Lasso di tempo: Day 6
|
Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
|
Day 6
|
|
Incidence of adverse effects associated with opioid use in the standard care (control) group
Lasso di tempo: Day 6
|
Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
|
Day 6
|
|
Incidence of adverse effects associated with opioid use in the experimental group
Lasso di tempo: Day 7
|
Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
|
Day 7
|
|
Incidence of adverse effects associated with opioid use in the standard care (control) group
Lasso di tempo: Day 7
|
Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
|
Day 7
|
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Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group
Lasso di tempo: Day 1
|
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.
Data collection via the Tess Monitoring Application
|
Day 1
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|
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group
Lasso di tempo: Day 1
|
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.
Data collection on the electronic clinical registration form
|
Day 1
|
|
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group
Lasso di tempo: Day 2
|
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.
Data collection via the Tess Monitoring Application
|
Day 2
|
|
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group
Lasso di tempo: Day 2
|
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.
Data collection on the electronic clinical monitoring form
|
Day 2
|
|
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group
Lasso di tempo: Day 3
|
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.
Data collection via the Tess Monitoring Application
|
Day 3
|
|
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group
Lasso di tempo: Day 3
|
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.
Data collection on the electronic clinical registration form
|
Day 3
|
|
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group
Lasso di tempo: Day 4
|
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application |
Day 4
|
|
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group
Lasso di tempo: Day 4
|
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.
Data collection on the electronic clinical registration form
|
Day 4
|
|
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group
Lasso di tempo: Day 5
|
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up. Data collection via the Tess Monitoring Application |
Day 5
|
|
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group
Lasso di tempo: Day 5
|
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.
Data collection on the electronic clinical registration form
|
Day 5
|
|
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group
Lasso di tempo: Day 6
|
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.
Data collection via the Tess Monitoring Application
|
Day 6
|
|
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group
Lasso di tempo: Day 6
|
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.
Data collection on the electronic clinical registration form
|
Day 6
|
|
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group
Lasso di tempo: Day 7
|
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.
Data collection via the Tess Monitoring Application
|
Day 7
|
|
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group
Lasso di tempo: Day 7
|
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.
Data collection on the electronic clinical monitoring form
|
Day 7
|
|
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group
Lasso di tempo: Month 1
|
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.
Data collection via the Tess Monitoring Application and a phone call to the patient
|
Month 1
|
|
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group
Lasso di tempo: Month 1
|
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.
Data collection on the electronic clinical registration form and a phone call to the patient
|
Month 1
|
|
Use of medication (including opioid medications and treatments outside the standard regimen) in the experimental group
Lasso di tempo: Month 3
|
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.
Data collection via the Tess Monitoring Application and a phone call to the patient
|
Month 3
|
|
Use of medication (including opioid medications and treatments outside the standard regimen) in the standard care (control) group
Lasso di tempo: Month 3
|
Collection of data on treatments prescribed outside the standard regimen and prescriptions issued on discharge from hospital up to three months of follow-up.
Data collection on the electronic clinical registration form and a phone call to the patient
|
Month 3
|
|
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group
Lasso di tempo: Day 1
|
Data collection via the Tess Monitoring Application
|
Day 1
|
|
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group
Lasso di tempo: Day 1
|
Data collection on the electronic clinical registration form
|
Day 1
|
|
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group
Lasso di tempo: Day 2
|
Data collection via the Tess Monitoring Application
|
Day 2
|
|
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group
Lasso di tempo: Day 2
|
Data collection on the electronic clinical registration form
|
Day 2
|
|
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group
Lasso di tempo: Day 3
|
Data collection via the Tess Monitoring Application
|
Day 3
|
|
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group
Lasso di tempo: Day 3
|
Data collection on the electronic clinical registration form
|
Day 3
|
|
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the experimental group
Lasso di tempo: Day 4
|
Data collection via the Tess Monitoring Application
|
Day 4
|
|
Number of unplanned medical appointments and telephone contacts with healthcare professionals after discharge from hospital in the standard care (control) group
Lasso di tempo: Day 4
|
Data collection on the electronic clinical registration form
|
Day 4
|
|
Prescription issued outside of those prescribed upon hospital discharge in the experimental group
Lasso di tempo: Month 3
|
Quantitative
|
Month 3
|
|
Prescription issued outside of those prescribed upon hospital discharge in the standard care(control) group
Lasso di tempo: Month 3
|
Quantitative
|
Month 3
|
|
Number of days of sick leave prescribed in the experimental group
Lasso di tempo: Month 3
|
Quantitative
|
Month 3
|
|
Number of days of sick leave prescribed in the standard care (control) group
Lasso di tempo: Month 3
|
Quantitative
|
Month 3
|
|
Satisfaction questionnaire administered to the patient in the experimental group
Lasso di tempo: Day 3
|
Qualitative
|
Day 3
|
|
Satisfaction questionnaire administered to the patient in the standard care (control) group
Lasso di tempo: Day 3
|
Qualitative
|
Day 3
|
|
Satisfaction questionnaire administered to the anesthesiologist in the experimental group
Lasso di tempo: End of the inclusion period
|
Qualitative
|
End of the inclusion period
|
|
Satisfaction questionnaire administered to the anesthesiologist in the standard care (control) group
Lasso di tempo: End of the inclusion period
|
Qualitative
|
End of the inclusion period
|
|
System Usability Scale score during the follow-up call to patients in the experimental group
Lasso di tempo: Day 30
|
The System Usability Scale (SUS) score is a measure of the usability of an interactive system, derived from a questionnaire that includes ten items.
Each item is presented as a positive statement, and users are asked to indicate their agreement or disagreement with it using a 5-point Likert scale.
The score is recalculated based on the number of items answered correctly, with a score of 2.5 for each item.
This scoring system allows the assessment of user satisfaction and the overall usability of the system.
|
Day 30
|
|
System Usability Scale score from health providers to the experimental group
Lasso di tempo: End of the inclusion period
|
The System Usability Scale (SUS) score is a measure of the usability of an interactive system, derived from a questionnaire that includes ten items.
Each item is presented as a positive statement, and users are asked to indicate their agreement or disagreement with it using a 5-point Likert scale.
The score is recalculated based on the number of items answered correctly, with a score of 2.5 for each item.
This scoring system allows the assessment of user satisfaction and the overall usability of the system.
|
End of the inclusion period
|
|
System Usability Scale score during the follow-up call to patients in the standard care (control) group
Lasso di tempo: Day 30
|
The System Usability Scale (SUS) score is a measure of the usability of an interactive system, derived from a questionnaire that includes ten items.
Each item is presented as a positive statement, and users are asked to indicate their agreement or disagreement with it using a 5-point Likert scale.
The score is recalculated based on the number of items answered correctly, with a score of 2.5 for each item.
This scoring system allows the assessment of user satisfaction and the overall usability of the system.
|
Day 30
|
|
System Usability Scale score from health providers to the standard care (control) group
Lasso di tempo: End of the inclusion period
|
The System Usability Scale (SUS) score is a measure of the usability of an interactive system, derived from a questionnaire that includes ten items.
Each item is presented as a positive statement, and users are asked to indicate their agreement or disagreement with it using a 5-point Likert scale.
The score is recalculated based on the number of items answered correctly, with a score of 2.5 for each item.
This scoring system allows the assessment of user satisfaction and the overall usability of the system.
|
End of the inclusion period
|
|
DN2 questionnaire score in the experimental group
Lasso di tempo: Post-operative Month 1
|
The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group.
It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching.
The cutoff for a positive DN2 result is set at 3 out of 7 points.
A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.
|
Post-operative Month 1
|
|
DN2 questionnaire score in the experimental group
Lasso di tempo: Post-operative Month 2
|
The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group.
It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching.
The cutoff for a positive DN2 result is set at 3 out of 7 points.
A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.
|
Post-operative Month 2
|
|
DN2 questionnaire score in the experimental group
Lasso di tempo: Post-operative Month 3
|
The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group.
It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching.
The cutoff for a positive DN2 result is set at 3 out of 7 points.
A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.
|
Post-operative Month 3
|
|
DN2 questionnaire score in the standard care (control) group
Lasso di tempo: Post-operative Month 1
|
The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group.
It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching.
The cutoff for a positive DN2 result is set at 3 out of 7 points.
A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.
|
Post-operative Month 1
|
|
DN2 questionnaire score in the standard care (control) group
Lasso di tempo: Post-operative Month 2
|
The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group.
It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching.
The cutoff for a positive DN2 result is set at 3 out of 7 points.
A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.
|
Post-operative Month 2
|
|
DN2 questionnaire score in the standard care (control) group
Lasso di tempo: Post-operative Month 3
|
The DN2 questionnaire is a simplified version of the DN4 (omitting the clinical examination), developed in France in 2005 by Bouhassira and the French Neuropathic Pain Group.
It consists of two questions assessing the presence or absence of seven symptoms suggestive of neuropathic pain : burning, painful cold, electric shocks, tingling, prickling, numbness, and itching.
The cutoff for a positive DN2 result is set at 3 out of 7 points.
A positive DN2 result does not establish a formal diagnosis of neuropathic pain, as a clinical examination remains essential.
|
Post-operative Month 3
|
|
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Lasso di tempo: Baseline
|
Patient's declaration in the Thess Monitoring Application
|
Baseline
|
|
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Lasso di tempo: Baseline
|
Phone call from the patient
|
Baseline
|
|
rate of adherence to the standard pain management regimen (non-opioid analgesics) in the in the standard care (control) group
Lasso di tempo: Day 1
|
Phone call from the patient
|
Day 1
|
|
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Lasso di tempo: Day 2
|
Patient's declaration in the Thess Monitoring Application
|
Day 2
|
|
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Lasso di tempo: Day 2
|
Phone call from the patient
|
Day 2
|
|
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Lasso di tempo: Day 3
|
Patient's declaration in the Thess Monitoring Application
|
Day 3
|
|
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Lasso di tempo: Day 3
|
Phone call from the patient
|
Day 3
|
|
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Lasso di tempo: Day 4
|
Patient's declaration in the Thess Monitoring Application
|
Day 4
|
|
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Lasso di tempo: Day 4
|
Phone call from the patient
|
Day 4
|
|
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Lasso di tempo: Day 5
|
Patient's declaration in the Thess Monitoring Application
|
Day 5
|
|
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Lasso di tempo: Day 5
|
Phone call from the patient
|
Day 5
|
|
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Lasso di tempo: Day 6
|
Patient's declaration in the Thess Monitoring Application
|
Day 6
|
|
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Lasso di tempo: Day 6
|
Phone call from the patient
|
Day 6
|
|
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the experimental group
Lasso di tempo: Day 7
|
Patient's declaration in the Thess Monitoring Application
|
Day 7
|
|
Rate of adherence to the standard pain management regimen (non-opioid analgesics) in the standard care (control) group
Lasso di tempo: Day 7
|
Phone call from the patient
|
Day 7
|
|
Incidence of adverse effects associated with opioid use in the experimental group
Lasso di tempo: Baseline
|
Adverse effects associated with opioid use will be recorded on the Thess Monitoring Application Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
|
Baseline
|
|
Incidence of adverse effects associated with opioid use in the standard care (control) group
Lasso di tempo: Baseline
|
Adverse effects associated with opioid use will be recorded via a phone call to the patient Nausea: yes/no Drowsiness: yes/no Dizziness: yes/no Itching: yes/no
|
Baseline
|
|
Adverse Events [Safety and Tolerability] in the experimental group
Lasso di tempo: Day 7
|
Qualitative assessment.
Any adverse events of any cause related to treatment will be recorded in the electronic clinical registration form following a phone call to the patient.
|
Day 7
|
|
Adverse Events [Safety and Tolerability]in the standard care (control) group
Lasso di tempo: Day 7
|
Qualitative assessment.
Any adverse events of any cause related to treatment will be recorded in the electronic clinical registration form following a phone call to the patient.
|
Day 7
|
|
Rate of incidents, malfunctions, and organization deviations that occurred during implementation in the experimental group
Lasso di tempo: Month 3
|
Qualitative
|
Month 3
|
|
Time spent connected to the Thess Monitoring device per patient in the experimental group
Lasso di tempo: Month 3
|
Quantitative, in minutes
|
Month 3
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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- Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
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- Demumieux F, Ludes PO, Diemunsch P, Bennett-Guerrero E, Lujic M, Lefebvre F, Noll E. Validation of the translated Quality of Recovery-15 questionnaire in a French-speaking population. Br J Anaesth. 2020 Jun;124(6):761-767. doi: 10.1016/j.bja.2020.03.011. Epub 2020 Apr 15.
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- Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
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- Bonnet A, Lavand'homme P, France MN, Reding R, De Kock M. [Postoperative pain trajectories to identify risk of chronic postsurgical pain in living donors for liver transplantation]. Ann Fr Anesth Reanim. 2012 Dec;31(12):945-9. doi: 10.1016/j.annfar.2012.09.011. Epub 2012 Oct 30. French.
- Chapman CR, Donaldson G, Davis J, Ericson D, Billharz J. Postoperative pain patterns in chronic pain patients: a pilot study. Pain Med. 2009 Apr;10(3):481-7. doi: 10.1111/j.1526-4637.2008.00522.x. Epub 2008 Nov 5.
- Chapman CR, Davis J, Donaldson GW, Naylor J, Winchester D. Postoperative pain trajectories in chronic pain patients undergoing surgery: the effects of chronic opioid pharmacotherapy on acute pain. J Pain. 2011 Dec;12(12):1240-6. doi: 10.1016/j.jpain.2011.07.005. Epub 2011 Oct 26.
- de Mos M, de Bruijn AG, Huygen FJ, Dieleman JP, Stricker BH, Sturkenboom MC. The incidence of complex regional pain syndrome: a population-based study. Pain. 2007 May;129(1-2):12-20. doi: 10.1016/j.pain.2006.09.008. Epub 2006 Nov 7.
- Duale C, Ouchchane L, Schoeffler P; EDONIS Investigating Group; Dubray C. Neuropathic aspects of persistent postsurgical pain: a French multicenter survey with a 6-month prospective follow-up. J Pain. 2014 Jan;15(1):24.e1-24.e20. doi: 10.1016/j.jpain.2013.08.014. Epub 2013 Oct 25.
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 dicembre 2025
Completamento primario (Stimato)
1 agosto 2026
Completamento dello studio (Stimato)
31 dicembre 2026
Date di iscrizione allo studio
Primo inviato
26 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
26 giugno 2026
Primo Inserito (Effettivo)
2 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IDIL/2024/JL01
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .