ClinicalTrials.gg
RecruitingNCT06571981RUTHUpdated Oct 30, 2026

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

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 2026-10-30.

Sponsored by Naik Vietti Violi · Observational

From the registry’s dates

  • Started Nov 2024; still recruiting 2 years later.
Updated Oct 30, 2026Primary completion movedStudy completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
102
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Hepatitis
  • Teleradiology

Browse trials for

03

In context

Hepatitis

343 studies on the registry are indexed under Hepatitis; 51 are open to participants now.

This study's planned enrollment of 102 is below the median of 358 across 90 observational studies indexed under Hepatitis.

Browse Hepatitis studies →

Lead sponsor

Naik Vietti Violi is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
102 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceTUP 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).

  • DeviceCUS 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).

06

What researchers measure

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

    Time frame: At the end of intervention

Secondary outcomes

  1. liver visualization scores

    no or minimal limitations; moderate limitations; severe limitations

    Time frame: At the end of intervention

  2. liver surface nodularity

    Yes/No

    Time frame: At the end of intervention

  3. focal lesions

    Yes/No

    Time frame: At the end of intervention

  4. caudate lobe dimensions

    cm

    Time frame: At the end of intervention

  5. portal flow velocity

    cm/s

    Time frame: At the end of intervention

  6. biliary tract / gallbladder abnormalities

    Yes/No

    Time frame: At the end of intervention

  7. lymph nodes presence

    Yes/No

    Time frame: At the end of intervention

  8. free fluid

    Yes/No

    Time frame: At the end of intervention

  9. examination time

    minutes

    Time frame: At the end of intervention

  10. audio quality

    Adequate/Non Adequate

    Time frame: At the end of intervention

  11. video quality

    Adequate/Non Adequate

    Time frame: At the end of intervention

  12. patient's satisfaction

    Yes/No

    Time frame: At the end of intervention

  13. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
1 site added, 1 site removed
Show site
  • Lausanne University Hospital · Lausanne, Switzerland
Show 1 removed
  • Lausanne University Hospital · Lausanne, Switzerland
Oct 30, 2026
Primary completion
Dec 31, 2025→Sep 30, 2026 (actual)
Oct 30, 2026
Study completion
Dec 31, 2025→Jul 30, 2027
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    1 site added, 1 site removed
    Show site
    • Lausanne University Hospital · Lausanne, Switzerland
    Show 1 removed
    • Lausanne University Hospital · Lausanne, Switzerland
    Primary completion Dec 31, 2025→Sep 30, 2026 (now actual)
    Study completion Dec 31, 2025→Jul 30, 2027
    + 2 other changes: verification date and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06571981
Lead sponsor
Naik Vietti Violi
Responsible party
Naik Vietti Violi (PD & MERc, Executive Physician of Diagnostic And Interventional Radiology Department, University of Lausanne Hospitals) — Sponsor-investigator
First posted
Aug 26, 2024
Start date
Nov 1, 2024
Primary completion
Sep 30, 2026
Completion
Jul 30, 2027 (estimated)
Last update
Oct 30, 2026

Study contacts

Naïk Vietti Violi, MD
Contact
naik.vietti-violi@chuv.ch
+41795560240
Giuseppe Gullo, MSc
Contact
giuseppe.gullo@chuv.ch
+41213144444
Naïk Vietti Violi, MD
study director · CHUV-UNIL

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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