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TEAS Timing for Gastrectomy Recovery (TEAS-TIME Trial)

15. Juli 2026 aktualisiert von: Zhou Yanbing, The Affiliated Hospital of Qingdao University

Effect of Perioperative vs Postoperative-Only Transcutaneous Electrical Acupoint Stimulation on Gastrointestinal Recovery and Pain Control After Laparoscopic Radical Gastrectomy: A Multicenter， Three-Arm, Randomized, Sham-Controlled Trial

The goal of this clinical trial is to learn if transcutaneous electrical acupoint stimulation (TEAS) works to help people recover faster after laparoscopic surgery for stomach cancer. TEAS is a treatment that uses small electrical pulses through sticky pads on the skin. It does not use needles.

The main questions it aims to answer are:

Does TEAS help people pass gas (a sign that the digestive system is waking up) sooner after surgery?

Does TEAS help lower pain after surgery?

Does TEAS reduce the need for extra pain medication after surgery?

Researchers will compare three groups to see if TEAS works better when given before, during, and after surgery compared with only after surgery.

Group 1 receives TEAS before, during, and after surgery.

Group 2 receives a sham (inactive) treatment before and during surgery, and real TEAS after surgery.

Group 3 receives sham treatment at all time points.

All participants will receive the same standard pain relief and recovery care after surgery.

Participants will:

Be randomly assigned (like flipping a coin) to one of the three groups

Receive TEAS or sham treatment for 30 minutes before surgery, during surgery, and for 30 minutes each day on the first 3 days after surgery

Rate their pain on a 0-10 scale at 6, 12, 24, 48, and 72 hours after surgery

Complete quality-of-life questionnaires before surgery, on day 4 after surgery, and 30 days after surgery

Have a follow-up visit or phone call 30 days after leaving the hospital

This study includes 300 adults aged 18 to 80 years who are scheduled to have laparoscopic surgery for stomach cancer at 13 hospitals in Shandong Province, China.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This study is a prospective, multicenter, three-arm, parallel-group, randomized, sham-controlled trial conducted at 13 tertiary hospitals in Shandong Province, China. A total of 300 eligible participants scheduled for laparoscopic radical gastrectomy for stage I-III gastric cancer will be enrolled and randomly assigned in a 1:1:1 ratio to one of three groups: Peri-TEAS (transcutaneous electrical acupoint stimulation administered before, during, and after surgery), Post-TEAS (sham treatment before and during surgery, with real TEAS after surgery), or Sham-TEAS (sham treatment at all time points). Randomization will be performed using a centralized system with stratification by study center and a randomized block design with randomly assigned block sizes. Allocation concealment is ensured by the system, with group assignments revealed only after participant enrollment.

TEAS is delivered using a standardized electroacupuncture device (SDZ-V, Suzhou Medical Products Factory) with a dense-disperse wave (2 Hz alternating with 100 Hz, 5s/10s duty cycle) at individually titrated intensities. Four bilateral acupoints are selected: Hegu (LI4), Neiguan (PC6), Zusanli (ST36), and Shangjuxu (ST37), following WHO standard acupoint locations. For the Peri-TEAS group, stimulation begins 30 minutes before anesthesia induction at the individually determined maximal tolerable threshold, continues throughout surgery at the same intensity, and resumes postoperatively for 30 minutes daily on postoperative days 1 through 3. For the Post-TEAS group, sham stimulation is applied before and during surgery, with real TEAS administered postoperatively using the same protocol as the Peri-TEAS group. The Sham-TEAS group receives sham stimulation at all time points. To maintain blinding, the device screen is shielded, and operators use standardized scripts to avoid unblinding.

All participants receive a standardized enhanced recovery after surgery (ERAS) protocol, including no bowel preparation, preoperative carbohydrate loading, minimally invasive incisions, goal-directed fluid therapy, no routine nasogastric tubes, early removal of drains and urinary catheters (within 24 hours), early mobilization, and a stepwise enteral nutrition plan. Postoperative analgesia is provided via patient-controlled intravenous analgesia (PCIA) with sufentanil (2 μg/kg in 100 mL normal saline, background infusion 2 mL/h, bolus 2 mL, lockout 15 min), supplemented with flurbiprofen axetil 50 mg twice daily. Rescue analgesia (morphine 2-4 mg IV or equivalent) is administered for breakthrough pain (NRS ≥ 4), with all rescue doses converted to morphine equivalent dose for analysis.

The primary endpoint is time to first flatus after surgery. Key secondary endpoints include the area under the curve of movement-evoked pain NRS scores over 0-72 hours and total rescue analgesic consumption in morphine equivalent dose. Additional secondary endpoints encompass gastrointestinal recovery parameters (time to first bowel movement, tolerance of liquid/semi-liquid/solid diets), pain and analgesic use (resting pain AUC, time to first PCIA press, total PCIA presses, intraoperative propofol and remifentanil dosages), ambulation and recovery (time to first independent ambulation ≥5 meters, postoperative hospital stay meeting uniform discharge criteria), and safety outcomes (incidence and severity of nausea, vomiting, abdominal distension, postoperative complications graded by Clavien-Dindo classification, and 30-day readmission rate). Patient-reported outcomes are assessed using the EORTC QLQ-C30 and QLQ-STO22 questionnaires, and perioperative fatigue is evaluated using the ICFS-10, all administered preoperatively, on postoperative day 4, and at 30 days after surgery. Exploratory endpoints include inflammatory cytokines (CRP, IL-6, IL-1β, TNF-α), gastrointestinal hormones (motilin, gastrin, substance P, VIP, cholecystokinin), and immunoglobulins (IgA, IgG, IgM) measured from fasting blood samples on postoperative days 1, 3, and 5 (or at discharge if earlier).

Blinding is implemented for participants, surgeons, anesthesiologists, outcome assessors, and statisticians. TEAS operators are not blinded but are strictly prohibited from participating in any post-treatment clinical assessments or data collection. The success of blinding will be evaluated using Bang's Blinding Index. An independent Data Monitoring Committee, composed of one statistician and two external experts, will regularly review safety and compliance data.

Sample size calculation: Based on pilot data showing a mean difference of 8.22 hours in time to first flatus between Peri-TEAS and Post-TEAS (SD 18.36) and 15.35 hours between Peri-TEAS and Sham-TEAS (SD 25.74), with α = 0.05 (two-sided) and power = 80%, 80 participants per group are required. Accounting for a 20% dropout rate, the target enrollment is 300 participants (100 per group).

The statistical analysis will follow a fixed-sequence testing procedure to control the overall type I error at α = 0.05. Analyses will be performed on the full analysis set (intention-to-treat principle), with per-protocol analysis for sensitivity. All tests will be two-sided, with statistical significance set at P < 0.05, using SAS 9.4.

The study protocol and informed consent form have been approved by the Ethics Committee of the Affiliated Hospital of Qingdao University and each participating center. The results will be disseminated through peer-reviewed academic journals.

Studientyp

Interventionell

Einschreibung (Geschätzt)

300

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • China
    • Shandong
      • Dongying, Shandong, China, 257091
        • Dongying People's Hospital
        • Kontakt:
          • Hao Wang
      • Qingdao, Shandong, China, 266000
        • Qingdao Municipal Hospital
        • Kontakt:
          • Hong Qi, MD
      • Qingdao, Shandong, China, 266000
        • Department of Gastrointestinal Surgery, Qingdao University Affiliated Hospital
        • Kontakt:
      • Qingdao, Shandong, China, 266041
        • The Third People's Hospital of Qingdao
        • Kontakt:
          • Xiaolei Liu
      • Qingdao, Shandong, China, 266042
        • Qingdao Central Hospital, University of Health and Rehabilitation Sciences
        • Kontakt:
          • Zhiwei Wang
      • Qingdao, Shandong, China, 266109
        • Peking University People's Hospital Qingdao
        • Kontakt:
          • Deju Wang
      • Qingdao, Shandong, China, 266109
        • Qingdao Chengyang District People's Hospital
        • Kontakt:
          • Baolian Song
      • Qingdao, Shandong, China, 266200
        • The People's Hospital of Jimo, Qingdao
        • Kontakt:
          • Hongbo Wang
      • Rizhao, Shandong, China, 276826
        • The People's Hospital of Rizhao
        • Kontakt:
          • Yang Yu
      • Weifang, Shandong, China, 261041
        • Weifang People's Hospital
        • Kontakt:
          • Jianjun Qu
      • Weihai, Shandong, China, 264400
        • Weihai Central Hospital
        • Kontakt:
          • Xinjian Wang
      • Weihai, Shandong, China, 264200
        • Weihai Municipal Hospital
        • Kontakt:
          • Shaowei Sun
      • Yantai, Shandong, China, 264000
        • Yantai Yuhuangding Hospital
        • Kontakt:
          • Jinchen Hu

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

Age 18 to 80 years, both sexes

Endoscopically and radiographically confirmed resectable stage I-III gastric cancer (AJCC 8th edition)

Scheduled to undergo laparoscopic radical gastrectomy

Willing to sign the informed consent form and able to comply with all study procedures

Exclusion Criteria:

American Society of Anesthesiologists (ASA) physical status ≥ IV

Clinical stage IV gastric cancer

Severe hepatic, renal, cardiovascular, or cerebrovascular diseases, or uncontrolled psychiatric disorders that may affect compliance or safety assessment

Participation in another clinical trial or receipt of any form of acupoint stimulation (acupuncture, electroacupuncture, TEAS, etc.) within 1 month prior to enrollment

Continuous use of opioids for more than 3 months prior to enrollment, with a daily dose ≥ 30 mg oral morphine equivalent

Implanted cardiac pacemaker or other electronic stimulation device, or skin infection/lesion at the stimulation site

Pregnancy or lactation

Emergency surgery due to bleeding, perforation, obstruction, etc.

Planned epidural anesthesia for the surgery

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Peri-TEAS Group
Participants receive active transcutaneous electrical acupoint stimulation (TEAS) before, during, and after surgery. Stimulation begins 30 minutes before anesthesia induction, continues throughout the surgery, and is repeated for 30 minutes daily on postoperative days 1 through 3.
Gerät: Transcutaneous Electrical Acupoint Stimulation
Transcutaneous electrical acupoint stimulation (TEAS) using the Hwato SDZ-V electronic acupuncture device (Suzhou Medical Appliance Factory Co., Ltd., China). Four bilateral acupoints are stimulated: Hegu (LI4), Neiguan (PC6), Zusanli (ST36), and Shangjuxu (ST37), following WHO standard locations. Stimulation parameters: dense-disperse wave (2 Hz alternating with 100 Hz, 5s/10s duty cycle, pulse width 0.2 ms ± 30%). Intensity is individually titrated to the maximal tolerable threshold using a dual-threshold calibration method.
Experimental: Post-TEAS Group
Participants receive sham (inactive) TEAS before and during surgery, and active TEAS after surgery. Postoperative stimulation is given for 30 minutes daily on postoperative days 1 through 3.
Gerät: Transcutaneous Electrical Acupoint Stimulation
Transcutaneous electrical acupoint stimulation (TEAS) using the Hwato SDZ-V electronic acupuncture device (Suzhou Medical Appliance Factory Co., Ltd., China). Four bilateral acupoints are stimulated: Hegu (LI4), Neiguan (PC6), Zusanli (ST36), and Shangjuxu (ST37), following WHO standard locations. Stimulation parameters: dense-disperse wave (2 Hz alternating with 100 Hz, 5s/10s duty cycle, pulse width 0.2 ms ± 30%). Intensity is individually titrated to the maximal tolerable threshold using a dual-threshold calibration method.
Schein-Komparator: Sham-TEAS Group
Participants receive sham (inactive) TEAS at all time points: before surgery, during surgery, and after surgery (postoperative days 1 through 3, 30 minutes daily).
Gerät: Sham Transcutaneous Electrical Acupoint Stimulation
Sham TEAS using the same Hwato SDZ-V device with identical appearance, indicator lights, and audible signals. The output leads are internally disconnected to deliver no electrical current. The operator performs the same procedural steps, including simulated dial adjustments, to maintain participant blinding.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time to First Flatus After Surgery
Zeitfenster: Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)
Time from the end of surgery to the patient's first self-reported passage of flatus. Patients and their families are instructed to record the exact time (to the nearest minute) immediately upon first flatus using a postoperative recovery diary card. Bedside nurses verify and collect the diary cards three times daily during rounds. Bowel movements induced by glycerin suppository or enema are excluded.
Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Area Under the Curve of Movement-Evoked Pain NRS Scores Over 0-72 Hours
Zeitfenster: 0 to 72 hours postoperatively
Area under the curve (AUC) of Numerical Rating Scale (NRS) scores for movement-evoked pain (MEP) from 0 to 72 hours postoperatively. NRS is a 11-point scale (0 = no pain, 10 = worst possible pain). Pain is assessed immediately after coughing using standardized instructions ("Please hold your wound with one hand, take a deep breath, and cough forcefully") at 6, 12, 24, 48, and 72 hours after surgery by a blinded assessor. If the patient cannot perform a standard cough, pain during turning in bed is assessed as a替代, with the reason recorded in the CRF. AUC is calculated using the trapezoidal rule. Pain during turning and ambulation are recorded simultaneously as exploratory analyses.
0 to 72 hours postoperatively
Total Rescue Analgesic Consumption in Morphine Equivalent Dose
Zeitfenster: From PACU admission (T0) until PCIA discontinuation (expected up to 72 hours postoperatively)
Total dose of all rescue analgesic medications administered for breakthrough pain (NRS ≥ 4) from PACU admission (T0) until discontinuation of PCIA and transition to oral analgesia, converted to morphine equivalent dose (mg MEDD) according to standard conversion factors: IV morphine 1 mg = 1 mg MEDD; IV hydromorphone 0.2 mg = 1 mg MEDD; IV tramadol 10 mg = 1 mg MEDD; oral oxycodone 1 mg = 1.5 mg MEDD. The date, time, and dose of each administration are captured concurrently from nursing medication records and the CRF.
From PACU admission (T0) until PCIA discontinuation (expected up to 72 hours postoperatively)
Time to First Bowel Movement
Zeitfenster: Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)
Time from the end of surgery to the first bowel movement, excluding those induced by glycerin suppository or enema.
Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)
Time to First Tolerance of Liquid Diet
Zeitfenster: Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)
Time from the end of surgery to first tolerance of a liquid diet, defined as the absence of vomiting or severe abdominal distension within 2 hours after ingestion.
Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)
Time to First Tolerance of Semi-Liquid Diet
Zeitfenster: Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)
Time from the end of surgery to first tolerance of a semi-liquid diet, defined as the absence of vomiting or severe abdominal distension within 2 hours after ingestion.
Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)
Time to First Tolerance of Solid Diet
Zeitfenster: Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)
Time from the end of surgery to first tolerance of a solid diet, defined as the absence of vomiting or severe abdominal distension within 2 hours after ingestion.
Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)
Area Under the Curve of Resting Pain NRS Scores Over 0-72 Hours
Zeitfenster: 0 to 72 hours postoperatively
Area under the curve (AUC) of Numerical Rating Scale (NRS) scores for resting pain (PAR, Pain at Rest) from 0 to 72 hours postoperatively. NRS is a 11-point scale (0 = no pain, 10 = worst possible pain). Assessed by a blinded assessor at 6, 12, 24, 48, and 72 hours after surgery. AUC is calculated using the trapezoidal rule.
0 to 72 hours postoperatively
Time to First PCIA Pump Press
Zeitfenster: Measured from the end of surgery up to 48 hours postoperatively
Time from the end of surgery to the patient's first postoperative patient-controlled intravenous analgesia (PCIA) pump activation.
Measured from the end of surgery up to 48 hours postoperatively
Total Number of PCIA Pump Presses Within 48 Hours Postoperatively
Zeitfenster: 0 to 48 hours postoperatively
Total number of patient-controlled intravenous analgesia (PCIA) pump presses (both effective and ineffective attempts) within the first 48 hours after surgery.
0 to 48 hours postoperatively
Intraoperative Propofol Dosage
Zeitfenster: During surgery (intraoperative)
Total intraoperative propofol dosage (mg) administered during surgery, recorded by the anesthesiologist.
During surgery (intraoperative)
Intraoperative Remifentanil Dosage
Zeitfenster: During surgery (intraoperative)
Total intraoperative remifentanil dosage (μg) administered during surgery, recorded by the anesthesiologist.
During surgery (intraoperative)
Time to First Independent Ambulation of ≥5 Meters
Zeitfenster: Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)
Time from the end of surgery to the patient's first independent ambulation of at least 5 meters.
Measured from the end of surgery up to hospital discharge (expected up to 7 days postoperatively)
Postoperative Hospital Stay
Zeitfenster: From the end of surgery to hospital discharge (expected up to 7 days postoperatively)
Duration of postoperative hospital stay (hours), defined as meeting the uniform discharge criteria: tolerance of oral analgesia, tolerance of a semi-liquid diet, passage of flatus, and absence of uncontrolled complications.
From the end of surgery to hospital discharge (expected up to 7 days postoperatively)
Incidence and Severity of Postoperative Nausea
Zeitfenster: 0 to 72 hours postoperatively
Incidence of postoperative nausea. Severity is assessed using the Numerical Rating Scale (NRS, 0 = no nausea, 10 = most severe nausea).
0 to 72 hours postoperatively
Incidence and Number of Episodes of Postoperative Vomiting
Zeitfenster: 0 to 72 hours postoperatively
Incidence and number of episodes of postoperative vomiting.
0 to 72 hours postoperatively
Rate of Rescue Antiemetic Use
Zeitfenster: 0 to 72 hours postoperatively
Rate of postoperative rescue antiemetic administration.
0 to 72 hours postoperatively
Incidence and Severity of Abdominal Distension
Zeitfenster: 0 to 72 hours postoperatively
Incidence of postoperative abdominal distension. Severity is assessed using the Numerical Rating Scale (NRS, 0 = no distension, 10 = most severe distension).
0 to 72 hours postoperatively
Incidence of Postoperative Complications
Zeitfenster: From the end of surgery up to 30 days post-discharge
Incidence of postoperative complications, graded by the Clavien-Dindo classification.
From the end of surgery up to 30 days post-discharge
30-Day Readmission Rate
Zeitfenster: 30 days after discharge
Rate of hospital readmission within 30 days after discharge.
30 days after discharge
Quality of Life - EORTC QLQ-C30
Zeitfenster: Preoperatively, on postoperative day 4, and at 30 days after surgery
Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The questionnaire assesses 15 dimensions of HRQoL, including physical, psychological, and social functions.
Preoperatively, on postoperative day 4, and at 30 days after surgery
Quality of Life - EORTC QLQ-STO22
Zeitfenster: Preoperatively, on postoperative day 4, and at 30 days after surgery
Gastric cancer-specific quality of life assessed using the EORTC Quality of Life Questionnaire - Stomach Cancer Module (EORTC QLQ-STO22). The questionnaire includes five multi-item scales (dysphagia, pain, reflux, eating restrictions, anxiety) and four single items (dry mouth, body image, taste problems, hair loss). Higher scores indicate more severe symptoms.
Preoperatively, on postoperative day 4, and at 30 days after surgery
Perioperative Fatigue - ICFS-10
Zeitfenster: Preoperatively, on postoperative day 4, and at 30 days after surgery
Perioperative fatigue assessed using the Identity-Consequence Fatigue Scale-10 (ICFS-10). The scale contains 10 items; a total score > 24 indicates postoperative fatigue syndrome (POF).
Preoperatively, on postoperative day 4, and at 30 days after surgery

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Inflammatory Cytokines - CRP, IL-6, IL-1β, TNF-α
Zeitfenster: Postoperative days 1, 3, and 5 (or at discharge if earlier)
Serum levels of inflammatory cytokines, including C-reactive protein (CRP), interleukin-6 (IL-6), interleukin-1β (IL-1β), and tumor necrosis factor-α (TNF-α), measured from fasting blood samples to investigate whether TEAS exerts its effects through inhibition of systemic inflammation.
Postoperative days 1, 3, and 5 (or at discharge if earlier)
Gastrointestinal Hormones - Motilin, Gastrin, Substance P, VIP, CCK
Zeitfenster: Postoperative days 1, 3, and 5 (or at discharge if earlier)
Serum levels of gastrointestinal hormones, including motilin (MTL), gastrin (GAS), substance P (SP), vasoactive intestinal peptide (VIP), and cholecystokinin (CCK), measured from fasting blood samples.
Postoperative days 1, 3, and 5 (or at discharge if earlier)
Immunoglobulins - IgA, IgG, IgM
Zeitfenster: Postoperative days 1, 3, and 5 (or at discharge if earlier)
Serum levels of immunoglobulins, including IgA, IgG, and IgM, measured from fasting blood samples to explore whether TEAS attenuates postoperative immunosuppression.
Postoperative days 1, 3, and 5 (or at discharge if earlier)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The Affiliated Hospital of Qingdao University

Ermittler

  • Studienstuhl: Yanbing Zhou, The Affiliated Hospital of Qingdao University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Juli 2028

Studienabschluss (Geschätzt)

1. August 2028

Studienanmeldedaten

Zuerst eingereicht

15. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Juli 2026

Zuerst gepostet (Tatsächlich)

20. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • TEAS-01

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

No plan for sharing individual participant data has been established for this investigator-initiated trial.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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