NCT05280145

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

Assessment of the echOpen Ultra-portable Ultrasound Device in Daily Use by Clinicians. Part II: Detection of Pyelocaliceal Dilation and Hepatic Steatosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The echOpen device includes an ultrasound probe and a mobile application. The mechanical probe emits at three ultrasound frequencies, 3.5 Mhz, 5.0 Mhz and 7.5 Mhz, which allows the exploration of the interior of the body at different depths in a non-invasive and non-irradiating manner. Thus, the purpose of the echOpen device is, on one hand, to guide the diagnosis during the clinical examination and, on the other hand, to identify anatomical structures in order to assist in management. The objective of the clinical investigation is to demonstrate that the echOpen device is able to identify semiological signs and localize anatomical structures at different depths of the body, with a performance not inferior to that of other ultrasound devices, routinely employed in hospital clinical departments. The signs of interest (i.e. detection of pyelocaliceal dilation (3.5 Mhz) and hepatic steatosis (5.0 Mhz) were chosen for their clinical usefulness (their identification during the clinical examination constitutes an argument for orientation and/or severity) and for their prevalence in the study population. An ultrasound probe in use in the hospital clinical departments where the investigation takes place will be employed as a comparator to judge the performance of the echOpen device. This clinical investigation is part of a CE marking procedure.

Conditions

• Hepatic Steatosis
• Fatty Liver
• Hydronephrosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-21
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2022-03-15
• Last updated: 2024-08-26

Locations

4 sites across 1 country: France