HepatitisRUTHNCT06571981
Conventional Ultrasound Versus Remote Ultraportable ulTrasound in the Context of Viral Hepatitis
An observational study of Hepatitis and Teleradiology, run by Naik Vietti Violi at 1 site in Switzerland.
Trial summary
Comparison of abdominal US exam in patients with viral hepatitis between ultraportable US with teleradiology capacities (TUP) versus conventional ultrasound (CUS) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis, Teleradiology
- What is being tested?
- TUP ultraportable US with teleradiology capacities and CUS conventional ultrasound
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2024to 30 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every outpatient referred to the radiology department by a prescriber for abdominal US in the context of viral hepatitis
Who may be able to join
- Informed Consent signed by the subject
- All adult patients with viral hepatitis for which an ultrasound is planned
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Lausanne University Hospital
Lausanne, Canton of Vaud, 1011
Naïk Vietti Violi, MD, +417955600240, naik.vietti-violi@chuv.ch
About this study
Official title: 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)
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
- Conditions
- Hepatitis, Teleradiology
- Being tested
- TUP ultraportable US with teleradiology capacities, CUS conventional ultrasound
- Medical subject headings
- Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUP ultraportable US with teleradiology capacitiesDevice
Comparison of abdominal ultrasound examinations in an at-risk population diagnosed with viral hepatitis: Ultraportable ultrasound with teleradiology capacities (TUP) versus conventional ultrasound (CUS).
CUS conventional ultrasoundDevice
Comparison of abdominal ultrasound examinations in an at-risk population diagnosed with viral hepatitis: Ultraportable ultrasound with teleradiology capacities (TUP) versus conventional ultrasound (CUS).
| Study group | Role | What they receive |
|---|---|---|
| Patients with viral hepatitis | Every outpatient referred to the radiology department by a prescriber for abdominal US in the context of viral hepatitis Receives: Device: TUP ultraportable US with teleradiology capacities; Device: CUS conventional ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the end of intervention
Secondary outcomes (13)
liver visualization scores
no or minimal limitations; moderate limitations; severe limitations
Measured: At the end of intervention
liver surface nodularity
Yes/No
Measured: At the end of intervention
focal lesions
Yes/No
Measured: At the end of intervention
caudate lobe dimensions
cm
Measured: At the end of intervention
portal flow velocity
cm/s
Measured: At the end of intervention
biliary tract / gallbladder abnormalities
Yes/No
Measured: At the end of intervention
lymph nodes presence
Yes/No
Measured: At the end of intervention
free fluid
Yes/No
Measured: At the end of intervention
examination time
minutes
Measured: At the end of intervention
audio quality
Adequate/Non Adequate
Measured: At the end of intervention
video quality
Adequate/Non Adequate
Measured: At the end of intervention
patient's satisfaction
Yes/No
Measured: 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.
Measured: At the end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Nov 2024
- Primary completion30 Sep 2026
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naik Vietti Violi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naik Vietti Violi, University of Lausanne Hospitals
- Investigators
- Naïk Vietti Violi, MD, Study director, CHUV-UNIL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571981
- Sponsor's protocol ID
- BASEC 2024-D0048
- Acronym
- RUTH
- Status last verified
- Mar 2026
- First submitted
- 19 Aug 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Conventional Ultrasound and Remote Ultraportable ulTrasound for Abdominal Examination in the Context of Viral Hepatitis
- ClinicalTrials.gov ID
- NCT06571981
- Acronym / sponsor ID
- RUTH / BASEC 2024-D0048
- Conditions
- Hepatitis, Teleradiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Naik Vietti VioliUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of abdominal US exam in patients with viral hepatitis between ultraportable US with teleradiology capacities (TUP) versus conventional ultrasound (CUS)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with viral hepatitis | – | Device: TUP ultraportable US with teleradiology capacities, Device: CUS conventional ultrasoundEvery outpatient referred to the radiology department by a prescriber for abdominal US in the context of viral hepatitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every outpatient referred to the radiology department by a prescriber for abdominal US in the context of viral hepatitis
Key inclusion criteria (2 listed)
- Informed Consent signed by the subject
- All adult patients with viral hepatitis for which an ultrasound is planned
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TUP ultraportable US with teleradiology capacitiesComparison of abdominal ultrasound examinations in an at-risk population diagnosed with viral hepatitis: Ultraportable ultrasound with teleradiology capacities (TUP) versus conventional ultrasound (CUS). | Device | Patients with viral hepatitis |
| CUS conventional ultrasoundComparison of abdominal ultrasound examinations in an at-risk population diagnosed with viral hepatitis: Ultraportable ultrasound with teleradiology capacities (TUP) versus conventional ultrasound (CUS). | Device | Patients with viral hepatitis |
Primary outcome
Comparison of TUP versus CUS for abdominal imaging in patients with viral hepatitis according to US LI-RADS categories ) for liver lesions
Time frame: At the end of intervention
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
13 secondary outcomes
liver visualization scores
Time frame: At the end of intervention
liver surface nodularity
Time frame: At the end of intervention
focal lesions
Time frame: At the end of intervention
caudate lobe dimensions
Time frame: At the end of intervention
portal flow velocity
Time frame: At the end of intervention
biliary tract / gallbladder abnormalities
Time frame: At the end of intervention
lymph nodes presence
Time frame: At the end of intervention
free fluid
Time frame: At the end of intervention
examination time
Time frame: At the end of intervention
audio quality
Time frame: At the end of intervention
video quality
Time frame: At the end of intervention
patient's satisfaction
Time frame: At the end of intervention
agreement rates between reports
Time frame: At the end of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Naïk Vietti Violi, MD study director
CHUV-UNIL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis and Teleradiology, run by Naik Vietti Violi at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naïk Vietti Violi, MD (+41795560240, naik.vietti-violi@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of TUP versus CUS for abdominal imaging in patients with viral hepatitis according to US LI-RADS categories ) for liver lesions (time frame: At the end of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.