An observational study in Hepatitis and Teleradiology, sponsored by Naik Vietti Violi. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by Naik Vietti Violi · Observational
Comparison of abdominal US exam in patients with viral hepatitis between ultraportable US with teleradiology capacities (TUP) versus conventional ultrasound (CUS)
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
Every outpatient referred to the radiology department by a prescriber for abdominal US in the context of viral hepatitis
Exclusion Criteria:
Every outpatient referred to the radiology department by a prescriber for abdominal US in the context of viral hepatitis
Device: TUP ultraportable US with teleradiology capacities · Device: CUS conventional ultrasound
Comparison of abdominal ultrasound examinations in an at-risk population diagnosed with viral hepatitis: Ultraportable ultrasound with teleradiology capacities (TUP) versus conventional ultrasound (CUS).
Comparison of abdominal ultrasound examinations in an at-risk population diagnosed with viral hepatitis: Ultraportable ultrasound with teleradiology capacities (TUP) versus conventional ultrasound (CUS).
Comparison of TUP versus CUS for abdominal imaging in patients with viral hepatitis according to US LI-RADS categories ) for liver lesions
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
Time frame: At the end of intervention
liver visualization scores
no or minimal limitations; moderate limitations; severe limitations
Time frame: At the end of intervention
liver surface nodularity
Yes/No
Time frame: At the end of intervention
focal lesions
Yes/No
Time frame: At the end of intervention
caudate lobe dimensions
cm
Time frame: At the end of intervention
portal flow velocity
cm/s
Time frame: At the end of intervention
biliary tract / gallbladder abnormalities
Yes/No
Time frame: At the end of intervention
lymph nodes presence
Yes/No
Time frame: At the end of intervention
free fluid
Yes/No
Time frame: At the end of intervention
examination time
minutes
Time frame: At the end of intervention
audio quality
Adequate/Non Adequate
Time frame: At the end of intervention
video quality
Adequate/Non Adequate
Time frame: At the end of intervention
patient's satisfaction
Yes/No
Time frame: At the end of intervention
agreement rates between reports
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.
Time frame: At the end of intervention
Plan to share: No
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Naik Vietti Violi