Lausanne University Hospital
Lausanne, Canton of Vaud, 1011, Switzerland
Location status: Recruiting
Recruiting
NCT Number: NCT06571981
Conventional Ultrasound Versus Remote Ultraportable ulTrasound 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)
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
TUP ultraportable US with teleradiology capacities
DeviceComparison 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 ultrasound
DeviceComparison of abdominal ultrasound examinations in an at-risk population diagnosed with viral hepatitis: Ultraportable ultrasound with teleradiology capacities (TUP) versus conventional ultrasound (CUS).
Primary outcomes
-
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
Secondary outcomes
-
liver visualization scores
Time frame: At the end of intervention
no or minimal limitations; moderate limitations; severe limitations
-
liver surface nodularity
Time frame: At the end of intervention
Yes/No
-
focal lesions
Time frame: At the end of intervention
Yes/No
-
caudate lobe dimensions
Time frame: At the end of intervention
cm
-
portal flow velocity
Time frame: At the end of intervention
cm/s
-
biliary tract / gallbladder abnormalities
Time frame: At the end of intervention
Yes/No
-
lymph nodes presence
Time frame: At the end of intervention
Yes/No
-
free fluid
Time frame: At the end of intervention
Yes/No
-
examination time
Time frame: At the end of intervention
minutes
-
audio quality
Time frame: At the end of intervention
Adequate/Non Adequate
-
video quality
Time frame: At the end of intervention
Adequate/Non Adequate
-
patient's satisfaction
Time frame: At the end of intervention
Yes/No
-
agreement rates between reports
Time frame: At the end of intervention
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Giuseppe Gullo, MSc
CONTACT
Naïk Vietti Violi, MD
CONTACT
Sponsors and collaborators
Lead sponsor
Naik Vietti Violi
Other
Registry information
Official study title
Comparison Between Conventional Ultrasound and Remote Ultraportable ulTrasound for Abdominal Examination in the Context of Viral Hepatitis
Acronym: RUTH
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Aug 26, 2024
- Registry last updated
- Apr 3, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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