Conventional Ultrasound Versus Remote Ultraportable ulTrasound in the Context of Viral Hepatitis

Recruiting

• Conditions: Teleradiology; Hepatitis
• Interventions: Device: TUP ultraportable US with teleradiology capacities; Device: CUS conventional ultrasound

• Registration Number: NCT06571981
• Lead Sponsor: Naik Vietti Violi

Brief Summary

Comparison of abdominal US exam in patients with viral hepatitis between ultraportable US with teleradiology capacities (TUP) versus conventional ultrasound (CUS)

Detailed Description

Primary Objective The investigation seeks primarily to determine the performance of abdominal US examinations realized with TUP and CUS based on defined imaging criteria Secondary Objectives Evaluate satisfaction and comfort and reproducibility of use of the ultraportable US

Study Timeline

• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-23
• Study First Posted: 2024-08-26
• Study Start: 2024-11-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Informed Consent signed by the subject
• All adult patients with viral hepatitis for which an ultrasound is planned

Exclusion Criteria

• Known or suspected non-compliance
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• Previous enrollment into the current study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with viral hepatitis	TUP ultraportable US with teleradiology capacities	Every outpatient referred to the radiology department by a prescriber for abdominal US in the context of viral hepatitis
Patients with viral hepatitis	CUS conventional ultrasound	Every outpatient referred to the radiology department by a prescriber for abdominal US in the context of viral hepatitis

Primary Outcome Measures

Name	Time	Method
Comparison of TUP versus CUS for abdominal imaging in patients with viral hepatitis according to US LI-RADS categories ) for liver lesions	At the end of intervention	LI RADS categories; No observation OR Only definitely benign observation(s) Observation(s) \< 10 mm in diameter, not definitely benign Observation(s) ≥ 10 mm in diameter, not definitely benign OR New thrombus in vein

Secondary Outcome Measures

Name	Time	Method
focal lesions	At the end of intervention	Yes/No
liver visualization scores	At the end of intervention	no or minimal limitations; moderate limitations; severe limitations
examination time	At the end of intervention	minutes
video quality	At the end of intervention	Adequate/Non Adequate
liver surface nodularity	At the end of intervention	Yes/No
caudate lobe dimensions	At the end of intervention	cm
biliary tract / gallbladder abnormalities	At the end of intervention	Yes/No
lymph nodes presence	At the end of intervention	Yes/No
free fluid	At the end of intervention	Yes/No
audio quality	At the end of intervention	Adequate/Non Adequate
portal flow velocity	At the end of intervention	cm/s
agreement rates between reports	At the end of intervention	Category 1: complete agreement/matching with teleradiologists reports; Category 2: minor discrepancy that would not impact patient management which included hedging terminology and ambiguous differences, for example fatty versus moderate fatty liver; Category 3: major discrepancy that would likely have an impact/change on patient management but would not lead to an adverse outcome for the patient; Category 4: major discrepancy that would impact patient management and lead to adverse outcomes for the patient.
patient's satisfaction	At the end of intervention	Yes/No

Trial Locations

Locations (1)

Lausanne University Hospital; 🇨🇭 Lausanne, Vaud, Switzerland