Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06774924

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEEchoscopy examination using the echOpen probeIn 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.

Timeline

Start date
2025-02-12
Primary completion
2026-09-30
Completion
2026-09-30
First posted
2025-01-14
Last updated
2025-12-26

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT06774924. Inclusion in this directory is not an endorsement.