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

Comparison Between Conventional Ultrasound and Remote Ultraportable ulTrasound for Abdominal Examination in the Context of Viral Hepatitis

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

Study Overview

• Status: Recruiting
• Conditions: Hepatitis; Teleradiology
• Intervention / Treatment: Device: TUP ultraportable US with teleradiology capacities; Device: CUS conventional ultrasound

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 Type: Observational
• Enrollment (Estimated): 102

Contacts and Locations

• Study Contact: Name: Naik Vietti Violi, MD; Phone Number: +41795560240; Email: naik.vietti-violi@chuv.ch
• Study Contact Backup: Name: Giuseppe Gullo, MSc; Phone Number: +41213144444; Email: giuseppe.gullo@chuv.ch

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Recruiting
      • Lausanne University Hospital
      • Contact: Naïk Vietti Violi, MD; Phone Number: +417955600240; Email: naik.vietti-violi@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
liver visualization scores	no or minimal limitations; moderate limitations; severe limitations	At the end of intervention
liver surface nodularity	Yes/No	At the end of intervention
focal lesions	Yes/No	At the end of intervention
caudate lobe dimensions	cm	At the end of intervention
portal flow velocity	cm/s	At the end of intervention
biliary tract / gallbladder abnormalities	Yes/No	At the end of intervention
lymph nodes presence	Yes/No	At the end of intervention
free fluid	Yes/No	At the end of intervention
examination time	minutes	At the end of intervention
audio quality	Adequate/Non Adequate	At the end of intervention
video quality	Adequate/Non Adequate	At the end of intervention
patient's satisfaction	Yes/No	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.	At the end of intervention

Collaborators and Investigators

• Sponsor: Naik Vietti Violi
• Investigators: Study Director: Naïk Vietti Violi, MD, CHUV-UNIL

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis A; Hepatitis
• Other Study ID Numbers: BASEC 2024-D0048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No