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

NCT06571981 | Recruiting DMC

• 1 other identifier: BASEC 2024-D0048
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatitis; Teleradiology

Outcome Measures

Primary Outcomes (1)

• 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

  At the end of intervention

Secondary Outcomes (13)

• liver visualization scores

  At the end of intervention

• liver surface nodularity

  At the end of intervention

• focal lesions

  At the end of intervention

• caudate lobe dimensions

  At the end of intervention

• portal flow velocity

  At the end of intervention

Study Arms (1)

Patients with viral hepatitis

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

Interventions

TUP ultraportable US with teleradiology capacities DEVICE

Comparison of abdominal ultrasound examinations in an at-risk population diagnosed with viral hepatitis: Ultraportable ultrasound with teleradiology capacities (TUP) versus conventional ultrasound (CUS).

Patients with viral hepatitis

CUS conventional ultrasound DEVICE

Comparison of abdominal ultrasound examinations in an at-risk population diagnosed with viral hepatitis: Ultraportable ultrasound with teleradiology capacities (TUP) versus conventional ultrasound (CUS).

Patients with viral hepatitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Every outpatient referred to the radiology department by a prescriber for abdominal US in the context of viral hepatitis

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Naik Vietti Violi: lead

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Hepatitis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Naïk Vietti Violi, MD

  CHUV-UNIL

  STUDY DIRECTOR

Central Study Contacts

Naïk Vietti Violi, MD

CONTACT

+41795560240; naik.vietti-violi@chuv.ch

Giuseppe Gullo, MSc

CONTACT

+41213144444; giuseppe.gullo@chuv.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD & MERc, Executive Physician of Diagnostic And Interventional Radiology Department

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 26, 2024
• Study Start: November 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)