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

Summary

In recent years, portable and ultra-portable ultrasound devices are increasingly used by the non radiologists, notably cardiologists or obstetrician gynecologist, at the patient's bedside to visualize and measure anatomical structures and fluid and provide the clinical examination with additional signs allowing quicker and more confident clinical decisions.

This innovative approach is slowed down by the accessibility of these miniaturized devices, the price of which remains high.

The echOpen device includes an ultra-portable ultrasound probe and a mobile application that allows the image to be displayed on a smartphone via a WIFI protocol.

The objective of the clinical investigation is to show that the echOpen device, using three frequencies 3.5 Mhz, 5.0 Mhz and 7.5 Mhz, allows identifying the semiological signs or anatomical structures of interest located at several depths of the body, with a performance similar to other devices routinely used in clinical departments.

Conditions

• Hepatic Steatosis
• Fatty Liver
• Hydronephrosis

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.

Sponsors & Collaborators

• ECHOPEN

  collaborator INDUSTRY

• EIT Health

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Jérôme BOKOBZA, MD · AP-HP, Cochin Hospital

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-21

Primary Completion

2023-11-17

Completion

2023-11-17

Countries

• France

Study Locations