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

NCT ID: NCT06774924

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-12
• Study Completion Date: 2026-09-30

Brief Summary

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.

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.

Conditions

Diagnosis; Clinical Ultrasound

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: OTHER

Echoscopy examination using the echOpen probe

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

patient and investigator satisfaction questionnaires

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne BOURGARIT, PUPH

Role: STUDY_DIRECTOR

HUPSSD

Locations

Unite de Diagnostic Rapide - Medecine Interne Hopital Jean Verdier

Bondy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Anne BOURGARIT, PUPH

Role: CONTACT

Phone: 00331 48 02 61 59

Email: anne.bourgarit@aphp.fr

Fadhila MESSANI

Role: CONTACT

Phone: 0033148957471

Email: fadhila.messani@aphp.fr

Facility Contacts

BOURGARIT ANNE, PUPH

Role: primary

Other Identifiers

N° IDRCB: 2024-A

Identifier Type: OTHER

Identifier Source: secondary_id

APHP 240421

Identifier Type: -

Identifier Source: org_study_id