Efficacy of the echOpen Device to Detect Pyelocaliceal Dilation and Hepatic Steatosis (CLIN-ECHO-II)

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

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.

Study Overview

• Status: Completed
• Conditions: Fatty Liver; Hepatic Steatosis; Hydronephrosis
• Intervention / Treatment: Device: EchOpen ultra-portable ultrasound device; Device: Ultrasound device routinely used in the department; Procedure: Ultrasound examination by an independent referent radiologist

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bobigny, France, 93140
    • Avicenne Hospital - APHP- Hepatology Department
  • Melun, France, 77000
    • Groupe Hospitalier Sud Ile de France (GHSIF) - Emergency Department
  • Paris, France, 75014
    • APHP COCHIN HOSPITAL - Emergency Department
  • Villejuif, France, 94800
    • Paul Brousse Hospital - APHP - Hepatobiliary Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patient (age ≥ 18 years old)
• Patient having signed the informed consent to participate in this clinical investigation
• Patient affiliated to the social security scheme

• Patient arriving in the hospital clinical ward (own initiative or by emergency services) whose clinical symptomatology suggests the presence of pathological elements which would be visible using an ultrasound probe in the following cases:

  • Search for pyelocaliceal dilation: patient consulting for abdominal and/or lumbar pain and/or iliac fossa, fever, pain in the right or left iliac fossa, anuresis
  • Search for hepatic steatosis: in a case of global clinical examination, abnormal laboratory test results, known or suspected metabolic disease, any situation suggesting the presence of hepatic steatosis

Exclusion Criteria:

• Minor patient (age < 18 years)
• Patients under the State Medical Assistance (AME)
• Obese patient (body mass index > 29.9)
• Patient in too serious condition for the clinical examination to be done fully and/or with additional exploratory time
• Unstable patient: need for immediate care, impossibility to carry out a thorough clinical examination including interview, palpation, auscultation, percussion
• Known allergy to ultrasound gel

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients benefitting ultrasound examination; This is the only arm of the study. Patients with an indicative clinical picture that leads the clinician to resort to the use of an ultrasound to potentially support the diagnosis, will be examined depending on clinical presentation for either the presence of pyelocaliceal dilatation, or hepatic steatosis. The patients will be assessed first with the echOpen device and second witn an ultrasound routinely used in the department. 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Pyelocaliceal dilation	Pyelocaliceal system assessment by using echOpen or a portable ultrasound routinely used in the department and scored as follows: 0, normal condition; 1, normal parenchyma, dilated renal pelvis, undilated calyces; 2, normal parenchyma, renal pelvis and calyces dilated, papillary impression preserved; 3, parenchyma thinned, significant pyelocaliceal dilation with bulging calyxes and disappearance of the papillary impression; 4, very thinned parenchyma, massive pyelocaliceal dilation, disappearance of the pyelocaliceal differentiation.	Day 0
Presence of Hepatic steatosis	Hepatic steatosis assessment by using echOpen or a portable ultrasound routinely used in the department and scored on the base of liver echogenicity as follows: 0, normal condition; 1, local hyperechogenicity; 2, diffuse hyperechogenicity	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pyelocaliceal dilation determined using a gold standard procedure	Pyelocaliceal system assessment by by an independent referent radiologist using a standard ultrasound machine and scored as follows: 0, normal condition; 1, normal parenchyma, dilated renal pelvis, undilated calyces; 2, normal parenchyma, renal pelvis and calyces dilated, papillary impression preserved; 3, parenchyma thinned, significant pyelocaliceal dilation with bulging calyxes and disappearance of the papillary impression; 4, very thinned parenchyma, massive pyelocaliceal dilation, disappearance of the pyelocaliceal differentiation.	Day 0
Hepatic steatosis determined using a gold standard procedure	Hepatic steatosis assessment by by an independent referent radiologist using a standard ultrasound machine and scored on the base of liver echogenicity as follows: 0, normal condition; 1, local hyperechogenicity; 2, diffuse hyperechogenicity	Day 0

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: EIT Health; ECHOPEN
• Investigators: Principal Investigator: Jérôme BOKOBZA, MD, AP-HP, Cochin hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2022
• Primary Completion (Actual): November 17, 2023
• Study Completion (Actual): November 17, 2023

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Ultrasound; Hepatic Steatosis; Ultrasonography; Point-of-care-ultrasound; pyelocaliceal system
• Additional Relevant MeSH Terms: Digestive System Diseases; Kidney Diseases; Urologic Diseases; Liver Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Fatty Liver; Hydronephrosis
• Other Study ID Numbers: APHP211147; 2021-A02168-33 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No