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RecruitingNCT06571981RUTHUpdated Apr 3, 2025

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 2025-04-03.

Sponsored by Naik Vietti Violi · Observational

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
03

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

Inclusion criteria

  • Informed Consent 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
04

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).

05

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

06

Study locations

1 of 1 sites recruiting
  • Lausanne University Hospital
    Lausanne, Vaud 1011, Switzerland
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 3, 2025

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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