Status:
COMPLETED
Efficacy of the echOpen Device to Detect Pyelocaliceal Dilation and Hepatic Steatosis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
ECHOPEN
EIT Health
Conditions:
Hepatic Steatosis
Fatty Liver
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05280145
Start Date
August 21 2022
End Date
November 17 2023
Last Update
August 26 2024
Active Locations (4)
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1
Avicenne Hospital - APHP- Hepatology Department
Bobigny, France, 93140
2
Groupe Hospitalier Sud Ile de France (GHSIF) - Emergency Department
Melun, France, 77000
3
APHP COCHIN HOSPITAL - Emergency Department
Paris, France, 75014
4
Paul Brousse Hospital - APHP - Hepatobiliary Center
Villejuif, France, 94800