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

Primary Purpose

Hepatic Steatosis, Fatty Liver, Hydronephrosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EchOpen ultra-portable ultrasound device
Ultrasound device routinely used in the department
Standard ultrasound examination by an independent referent radiologist
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hepatic Steatosis focused on measuring Ultrasound, Ultrasonography, Point-of-care-ultrasound, Hepatic Steatosis, pyelocaliceal system

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Avicenne Hospital - APHP- Hepatology DepartmentRecruiting
  • Groupe Hospitalier Sud Ile de France (GHSIF) - Emergency DepartmentRecruiting
  • APHP COCHIN HOSPITAL - Emergency DepartmentRecruiting
  • Paul Brousse Hospital - APHP - Hepatobiliary CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients benefitting ultrasound examination

Arm Description

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 to verify the presence of pleural effusion or intra-abdominal effusion, or to identify basilic vein. 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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.
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

Full Information

First Posted
March 4, 2022
Last Updated
July 27, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
ECHOPEN, EIT Health
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1. Study Identification

Unique Protocol Identification Number
NCT05280145
Brief Title
Efficacy of the echOpen Device to Detect Pyelocaliceal Dilation and Hepatic Steatosis
Acronym
CLIN-ECHO-II
Official Title
Assessment of the echOpen Ultra-portable Ultrasound Device in Daily Use by Clinicians. Part II: Detection of Pyelocaliceal Dilation and Hepatic Steatosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
ECHOPEN, EIT Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Steatosis, Fatty Liver, Hydronephrosis
Keywords
Ultrasound, Ultrasonography, Point-of-care-ultrasound, Hepatic Steatosis, pyelocaliceal system

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients benefitting ultrasound examination
Arm Type
Experimental
Arm Description
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 to verify the presence of pleural effusion or intra-abdominal effusion, or to identify basilic vein. 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.
Intervention Type
Device
Intervention Name(s)
EchOpen ultra-portable ultrasound device
Intervention Description
Depending on the clinical picture, the patient is examined with EchOpen to detect the presence or absence of pyelocaliceal dilation or hepatic steatosis
Intervention Type
Device
Intervention Name(s)
Ultrasound device routinely used in the department
Intervention Description
Patient who was first examined with EchOpen, is secondarily examined with an ultrasound probe used routinely in the department to detect pyelocaliceal dilation or hepatic steatosis
Intervention Type
Procedure
Intervention Name(s)
Standard ultrasound examination by an independent referent radiologist
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence of Pyelocaliceal dilation
Description
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.
Time Frame
Day 0
Title
Presence of Hepatic steatosis
Description
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
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Pyelocaliceal dilation determined using a gold standard procedure
Description
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.
Time Frame
Day 0
Title
Hepatic steatosis determined using a gold standard procedure
Description
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
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jérôme BOKOBZA, MD
Phone
+33 (0)158412707
Email
jerome.bokobza@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérôme BOKOBZA, MD
Organizational Affiliation
AP-HP, Cochin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avicenne Hospital - APHP- Hepatology Department
City
Bobigny
ZIP/Postal Code
93140
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Charles NAULT, MD, PhD
Phone
01 48 02 68 03
Ext
+33
Email
jean-charles.nault@aphp.fr
First Name & Middle Initial & Last Name & Degree
Jean-Charles NAULT, MD, PhD
Facility Name
Groupe Hospitalier Sud Ile de France (GHSIF) - Emergency Department
City
Melun
ZIP/Postal Code
77000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain BOKOBZA, MD
Phone
+33 1 81 74 47 67.
Email
romain.bokobza@ghsif.fr
First Name & Middle Initial & Last Name & Degree
David SAPIR, MD
First Name & Middle Initial & Last Name & Degree
Romain BOKOBZA, MD
Facility Name
APHP COCHIN HOSPITAL - Emergency Department
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerome BOKOBZA, MD
Phone
01 58 41 27 07
Ext
+33
Email
jerome.bokobza@aphp.fr
First Name & Middle Initial & Last Name & Degree
Jerome BOKOBZA, MD
Facility Name
Paul Brousse Hospital - APHP - Hepatobiliary Center
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Vibert, MD, PhD
Phone
01 45 59 33 31
Ext
+33
Email
eric.vibert@aphp.fr
First Name & Middle Initial & Last Name & Degree
Eric Vibert, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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