Clinical trial NCT05280145: Efficacy of the echOpen Device to Detect Pyelocaliceal Dilation and Hepatic Steatosis
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
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Steatosis
Fatty Liver
Hydronephrosis
Keywords: Ultrasound
Ultrasonography
Point-of-care-ultrasound
Hepatic Steatosis
pyelocaliceal system
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: ECHOPEN
name: EIT Health
First posted: 2022-03-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Presence of Pyelocaliceal dilation
timeFrame: Day 0
measure: Presence of Hepatic steatosis
timeFrame: Day 0
Secondary outcomes:
measure: Pyelocaliceal dilation determined using a gold standard procedure
timeFrame: Day 0
measure: Hepatic steatosis determined using a gold standard procedure
timeFrame: Day 0
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Avicenne Hospital - APHP- Hepatology Department
city: Melun
country: France
facility: Groupe Hospitalier Sud Ile de France (GHSIF) - Emergency Department
city: Paris
country: France
facility: APHP COCHIN HOSPITAL - Emergency Department
city: Villejuif
country: France
facility: Paul Brousse Hospital - APHP - Hepatobiliary Center
Study officials:
affiliation: AP-HP, Cochin Hospital
name: Jérôme BOKOBZA, MD
role: PRINCIPAL_INVESTIGATOR
References: