Bringing handheld echOpen ultrasound to link neighborhood clinics with Jean Verdier Hospital

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

This project will test using a handheld echOpen ultrasound probe by hospital and community clinicians to see if it shortens time to diagnosis for adults referred to Jean Verdier's Rapid Diagnostic Unit.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Bondy)
• Trial ID: NCT06774924 on ClinicalTrials.gov

What this trial studies

The intervention introduces the echOpen handheld ultrasound probe in a three-phase rollout across the Jean Verdier Rapid Diagnostic Unit (UDR), referring outpatient clinics, and a mobile Health Bus. Each phase begins with clinician training followed by prospective use of the probe during patient evaluations, with data collected on time to diagnosis, diagnostic accuracy, and use of additional tests. The protocol enrolls consenting adults referred to participating sites and excludes those on the UDR iron-deficiency anemia pathway, patients with BMI >34.9 kg/m2, life‑threatening emergencies, or those unable to communicate in French without a translator. Primary process outcomes include diagnostic timing and downstream changes such as direct access to biopsy and reduced complementary examinations.

Who should consider this trial

Good fit: Adults (≥18) referred to the Jean Verdier UDR from participating structures or seen by the Health Bus who can give informed consent and communicate in French or via a translator are ideal candidates.

Not a fit: Patients on the iron‑deficiency anemia clinical pathway, those with BMI >34.9 kg/m2, people requiring immediate life‑saving care, or those who cannot communicate in French and lack a translator are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, patients could get faster and more accurate diagnoses with fewer additional tests and quicker access to needed biopsy or treatment.

How similar studies have performed: Point‑of‑care ultrasound performed by non-radiologist clinicians has previously shortened diagnostic time and reduced additional imaging in emergency and primary care settings, though deploying the echOpen probe across this specific regional care pathway is novel.

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.

Where this trial is running

Bondy

• Unite de Diagnostic Rapide - Medecine Interne Hopital Jean Verdier — Bondy, France (Recruiting)

Study contacts

• Study coordinator: Anne BOURGARIT, PUPH

Conditions Diagnosis; Clinical Ultrasound