Efficacy of the echOpen Device to Detect Pyelocaliceal Dilation and Hepatic Steatosis

NACompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

August 21, 2022

Primary Completion Date

November 17, 2023

Study Completion Date

November 17, 2023

Conditions
Hepatic SteatosisFatty LiverHydronephrosis
Interventions
DEVICE

EchOpen ultra-portable ultrasound device

Depending on the clinical picture, the patient is examined with EchOpen to detect the presence or absence of pyelocaliceal dilatation or hepatic steatosis

DEVICE

Ultrasound device routinely used in the department

Patient who was first examined with EchOpen, is secondarily examined with an ultrasound probe used routinely in the department to detect pyelocaliceal dilatation or hepatic steatosis

PROCEDURE

Ultrasound examination by an independent referent radiologist

In a case of discordance between the assessments made with echOpen and the usual ultrasound device, an independent referent radiologist will use a standard ultrasound machine to constitute the gold standard (GS) rating. If the latter is not available to carry out the third ultrasound scan within a timeframe deemed clinically acceptable, then the evaluation will be carried out in a delayed manner, using the video loops and image captures saved during the two initial ultrasound scans.

Trial Locations (4)

75014

APHP COCHIN HOSPITAL - Emergency Department, Paris

77000

Groupe Hospitalier Sud Ile de France (GHSIF) - Emergency Department, Melun

93140

Avicenne Hospital - APHP- Hepatology Department, Bobigny

94800

Paul Brousse Hospital - APHP - Hepatobiliary Center, Villejuif

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

ECHOPEN

INDUSTRY

collaborator

EIT Health

OTHER

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT05280145 - Efficacy of the echOpen Device to Detect Pyelocaliceal Dilation and Hepatic Steatosis | Biotech Hunter | Biotech Hunter