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

NCT05280145 | Completed

• 2 other identifiers: APHP2111472021-A02168-33
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Ultrasound; Ultrasonography; Point-of-care-ultrasound; Hepatic Steatosis; pyelocaliceal system

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pyelocaliceal dilation determined using a gold standard procedure

  Day 0

• Hepatic steatosis determined using a gold standard procedure

  Day 0

Study Arms (1)

Patients benefitting ultrasound examination

EXPERIMENTAL

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; Device: Ultrasound device routinely used in the department; Procedure: Ultrasound examination by an independent referent radiologist

Interventions

EchOpen ultra-portable ultrasound device DEVICE

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

Patients benefitting ultrasound examination

Ultrasound device routinely used in the department DEVICE

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

Patients benefitting ultrasound examination

Ultrasound examination by an independent referent radiologist PROCEDURE

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.

Patients benefitting ultrasound examination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• ECHOPEN: collaborator
• EIT Health: collaborator

Study Sites (4)

Avicenne Hospital - APHP- Hepatology Department

Bobigny, 93140, France

Location

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

Melun, 77000, France

Location

APHP COCHIN HOSPITAL - Emergency Department

Paris, 75014, France

Location

Paul Brousse Hospital - APHP - Hepatobiliary Center

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Fatty Liver; Hydronephrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jérôme BOKOBZA, MD

  AP-HP, Cochin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single group, comparative, non-randomized, controlled study. Each patient represents her/his own control: the patient is examined consecutively with the echOpen probe, then with the probe routinely used in the department

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 15, 2022
• Study Start: August 21, 2022
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

FR (4)