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

NCT06774924 | Recruiting

• 2 other identifiers: APHP 240421N° IDRCB: 2024-A
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diagnosis; Clinical Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  Through study completion, an average of 2 years for phase 1 and 2, at each inclusion visit of patient (day 1) for phase 3

Study Arms (1)

echoscopy examination using the echOpen probe

OTHER

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

Interventions

Echoscopy examination using the echOpen probe 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.

Also known as: patient and investigator satisfaction questionnaires

echoscopy examination using the echOpen probe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient over 18 years of age
• Patient with signed informed consent
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Unite de Diagnostic Rapide - Medecine Interne Hopital Jean Verdier

Bondy, France

RECRUITING

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne BOURGARIT, PUPH

  HUPSSD

  STUDY DIRECTOR

Central Study Contacts

Anne BOURGARIT, PUPH

CONTACT

00331 48 02 61 59; anne.bourgarit@aphp.fr

Fadhila MESSANI

CONTACT

0033148957471; fadhila.messani@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: January 14, 2025
• Study Start: February 12, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-10

Locations

FR (1)