Efficacy of the echOpen Device to Identify Effusion and to Detect Basilic Vein

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

• Pleural Effusion
• Abdominal Effusion
• Procedural Guidance

Interventions

DEVICE

EchOpen ultra-portable ultrasound device

Depending on the clinical picture, patients are examined to detect the presence or absence of pleural effusion, or intra-abdominal effusion, or to localize the basilic vein

DEVICE

Ultrasound device routinely used in the department.

Patients who were first examined with the EchOpen ultra-portable ultrasound device, are secondarily examined with an ultrasound probe used routinely in the department.

PROCEDURE

Standard 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

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

2022-04-04

Primary Completion

2022-08-19

Completion

2022-08-19

Countries

• France

Study Locations