"Clinical Ultrasound, a New Link Between Town and Hospital in Seine-Saint-Denis". (ECHO93) (ECHO93)

The ECHO93 study is a non-healthcare interventional study. Its aim is to evaluate the effect of introducing the echOpen probe into the management of patients referred to the Jean Verdier UDR, in terms of time to diagnosis.

The study is divided into 3 phases:

Phase 1: opening of the Rapid Diagnosis Unit (UDR) at Jean Verdier Hospital Phase 2: Opening of the Jean Verdier Hospital UDR, MSP Pantin, Dr TAYBALY's medical practice in Aulnay-sous-Bois, one month after the start of phase 1.

Phase 3: Opening of the Jean Verdier Hospital Health Bus, one month after the start of phase 2.

Study Overview

• Status: Recruiting
• Conditions: Diagnosis; Clinical Ultrasound
• Intervention / Treatment: Device: Echoscopy examination using the echOpen probe

Detailed Description

This research will be carried out in 3 phases:

• Phase 1: implementation of the tool within the hospital for UDR doctors and evaluation of the effect of this implementation on the organizations: shorter time to diagnosis, increased accuracy of diagnosis, reduced number of complementary examinations. This first phase will begin with EchOpen training for doctors, and will continue with inclusions and testing of the added value of using the probe within the UDR.
• Phase 2: implementation of the tool in the structures referring patients to the UDR, whether the SAU de Jean Verdier, for clearing before referral to the UDR, or the structures of town doctors (CPTS Livry Gargan, MSP Pantin and Cabinet Médical du Dr TAYBALY at Aulnay-sous-Bois) for clearing before referral to the UDR. As in phase 1, the aim is to assess the effect of the new approach on organization, and to report on follow-up indicators, such as the number of patients with direct access to biopsy, the reduction in diagnosis time, and the targeting and reduction of additional examinations. This second phase will begin one month after phase 1, starting with EchOpen training for doctors and continuing with inclusions and experimentation within the adult emergency departments of Jean Verdier Hospital and the multi-professional health centers named above.
• Phase 3: implementation of the tool in the Health Bus, as part of the "go-to" approach. The monitoring indicator will be the number of situations in which the echOpen solution has made it possible to sort between pathologies that require an emergency service or that can be managed in the Health Bus. This third phase will begin one month after phase 2, starting with EchOpen training for doctors and continuing with inclusions and testing of the probe in the Health Bus.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne BOURGARIT, PUPH; Phone Number: 00331 48 02 61 59; Email: anne.bourgarit@aphp.fr
• Study Contact Backup: Name: Fadhila MESSANI; Phone Number: 0033148957471; Email: fadhila.messani@aphp.fr

Study Locations

• France
  • Bondy, France
    • Recruiting
    • Unite de Diagnostic Rapide - Medecine Interne Hopital Jean Verdier
    • Contact: BOURGARIT ANNE, PUPH; Phone Number: 0148026159; Email: anne.bourgarit@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult patient over 18 years of age
2. Patient with signed informed consent

3. Patient managed by:

   • one of the structures involved (UDR/ SAU Jean Verdier, MSP Pantin, Cabinet Médical du Dr TAYBALY à Aulnay-sous-Bois) for referral to the UDR for rapid diagnosis (phases 1 and 2)
   • the Health Bus (phase 3)

Exclusion Criteria:

1. Patient on the UDR iron-deficiency anemia clinical pathway
2. Patient deprived of liberty by judicial or administrative decision
3. Patient who does not speak French and cannot benefit from the presence of a relative or translator (physical or online)

4. Patient with a contraindication to the use of EchOPen:

   • patients with a body mass index greater than 34.9 kg/m2
   • life-threatening patients requiring emergency medical care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: echoscopy examination using the echOpen probe; In addition to standard care, each patient will have a systematic 4-point echoscopy examination using the echOpen probe: liver, spleen, lymph nodes, thyroid and, depending on symptoms, lung, kidney, bladder, abdomen. The echOpen probe is CE marked. It will be used for all indications except certain areas of the body (thyroid, lymph nodes, bladder, liver, spleen, kidney, bladder and lymph nodes).

Device: Echoscopy examination using the echOpen probe; In addition to standard care, each patient will have a systematic 4-point echoscopy examination using the echOpen probe: liver, spleen, lymph nodes, thyroid and, depending on symptoms, lung, kidney, bladder, abdomen. The echOpen probe is CE marked. It will be used for all indications except certain areas of the body (thyroid, lymph nodes, bladder, liver, spleen, kidney, bladder and lymph nodes). In addition to echoscopy with the echOpen probe, patient and physician satisfaction questionnaires will be used as part of this study.; Other Names: patient and investigator satisfaction questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the effect of introducing the echOpen probe into the management of patients referred to the Jean Verdier Rapid Diagnostic Unit (UDR) on time to diagnosis.	The time between the first contact with the Rapid Diagnosis Unit (RDU) and the date of the diagnosis (date of discharge from the RDU) in patients who had an ultrasound scan with the echOpen probe in consultation at the RDU (phase 1) and in patients who had it in consultation with a general practitioner or in the emergency department (phase 2), compared with the time before the echOpen was introduced.	Visite discharge from the RDU ( Maximum 2 months after inclusion visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effect of introducing the echOpen probe in the management of patients referred to the Jean Verdier UDR on time to diagnosis according to where the tool is used.	- The number of complementary examinations prescribed/avoided, in comparison with the number of examinations prior to the introduction of the echOpen.	Visite discharge from the RDU ( Maximum 2 months after inclusion visit)
Evaluate the effect of introducing the echOpen probe in the management of patients referred to the Jean Verdier UDR on time to diagnosis according to where the tool is used.	- The time between the first consultation and the radioguided biopsy, if this is to be carried out	Visite discharge from the RDU ( Maximum 2 months after inclusion visit)
Evaluate the effect of introducing the echOpen probe in the management of patients referred to the Jean Verdier UDR on time to diagnosis according to where the tool is used.	- The number of patients accessing the UDR day hospital directly will be evaluated in patients having had an echoscopy with the echOpen probe in consultation at the UDR (phase 1) in comparison with the number of patients before the introduction of the echOpen.	Visite discharge from the RDU ( Maximum 2 months after inclusion visit)
Evaluate the effect of introducing the echOpen probe in the management of patients referred to the Jean Verdier UDR on time to diagnosis according to where the tool is used.	- The number of patients referred to the emergency department facilitated by the echOpen probe will be evaluated among patients who had an echOpen probe in the Health Bus (phase 3), compared with the number of patients before the echOpen was introduced.	Visite discharge from the RDU ( Maximum 2 months after inclusion visit)
Evaluate the satisfaction of physicians participating in the study with the introduction of the echOpen probe in the management of patients referred to the Jean Verdier UDR.	Physician satisfaction (phases 1 and 2) will be assessed by a questionnaire carried out at the end of the study. For Health Bus doctors (phase 3), the questionnaire will be completed after each patient consultation. A visual analog scale will be proposed in this questionnaire to assess doctors' overall satisfaction with the use of EchOpen. This scale ranges from 0 (very dissatisfied) to 10 (very satisfied).	Through study completion, an average of 2 years for phase 1 and 2, at each inclusion visit of patient (day 1) for phase 3
Evaluate the satisfaction of physicians participating in the study with the introduction of the echOpen probe in the management of patients referred to the Jean Verdier UDR.	Physicians' satisfaction will also be assessed by a weekly questionnaire sent directly to them by the EchOpen team.	once a week throughout the entire inclusion period which is 16 months
To assess patient satisfaction with the introduction of the echOpen probe in the management of patients referred to the Jean Verdier UDR.	Patient satisfaction (phases 1 and 2) will be assessed by a questionnaire administered on discharge from the UDR. For Health Bus patients (phase 3), the questionnaire will be carried out at the Inclusion/Final visit. This questionnaire will include a visual analog scale to assess patients' overall satisfaction with the EchOpen. The scale ranges from 0 (very dissatisfied) to 10 (very satisfied).	Visit discharge from the RDU ( Maximum 2 months after inclusion visit) for pahse 1 and 2. At the Inclusion visit (day 1) for phase 3

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Anne BOURGARIT, PUPH, HUPSSD

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): January 14, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease
• Other Study ID Numbers: APHP 240421; N° IDRCB: 2024-A (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No