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

Not Applicable

Completed

• Conditions: Hepatic Steatosis; Fatty Liver; Hydronephrosis

• Registration Number: NCT05280145
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-3-4
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Inclusion Criteria:<br><br> - Adult patient (age = 18 years old)<br><br> - Patient having signed the informed consent to participate in this clinical<br> investigation<br><br> - Patient affiliated to the social security scheme<br><br> - Patient arriving in the hospital clinical ward (own initiative or by emergency<br> services) whose clinical symptomatology suggests the presence of pathological<br> elements which would be visible using an ultrasound probe in the following cases:<br><br> - Search for pyelocaliceal dilation: patient consulting for abdominal and/or<br> lumbar pain and/or iliac fossa, fever, pain in the right or left iliac fossa,<br> anuresis<br><br> - Search for hepatic steatosis: in a case of global clinical examination,<br> abnormal laboratory test results, known or suspected metabolic disease, any<br> situation suggesting the presence of hepatic steatosis<br><br>Exclusion Criteria:<br><br> - Minor patient (age < 18 years)<br><br> - Patients under the State Medical Assistance (AME)<br><br> - Obese patient (body mass index > 29.9)<br><br> - Patient in too serious condition for the clinical examination to be done fully<br> and/or with additional exploratory time<br><br> - Unstable patient: need for immediate care, impossibility to carry out a thorough<br> clinical examination including interview, palpation, auscultation, percussion<br><br> - Known allergy to ultrasound gel

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of Pyelocaliceal dilation;Presence of Hepatic steatosis

Secondary Outcome Measures

Name	Time	Method
Pyelocaliceal dilation determined using a gold standard procedure;Hepatic steatosis determined using a gold standard procedure