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Recruiting NCT06774924

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

No phase Interventional Diagnosis Clinical Ultrasound

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Echoscopy examination using the echOpen probe.
Who it may be relevant to
Registry conditions: Diagnosis, Clinical Ultrasound. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • 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. [Time frame: Visite discharge from the RDU ( Maximum 2 months after inclusion visit)]
Secondary outcome measures (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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Unite de Diagnostic Rapide - Medecine Interne Hopital Jean Verdier — Bondy

Identifiers

NCT: NCT06774924 · APHP 240421 · N° IDRCB: 2024-A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗