Evaluation of Elastosonographic Techniques Implemented on Ultrasound Systems for the Assessment o… (NCT07302152) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Elastosonographic Techniques Implemented on Ultrasound Systems for the Assessment of Liver Stiffness
Italy72 participantsStarted 2023-03-16
Plain-language summary
The assessment of liver stiffness is essential in patients with suspected or confirmed chronic liver disease, as clinical management depends on the degree and progression of hepatic fibrosis, which increases liver hardness. In recent years, non-invasive elastosonographic techniques have been introduced to estimate liver fibrosis. The first to be implemented was Transient Elastography (TE), which has shown high accuracy in identifying significant fibrosis and cirrhosis, particularly in patients with HCV-related chronic liver disease, and has been endorsed by The European Association for the Study of the Liver (EASL) guidelines as an alternative to liver biopsy. More recently, shear-wave elastography techniques integrated into conventional ultrasound systems have been developed, offering the advantage of real-time B-mode ultrasound guidance. The aim of this study is to compare these techniques with each other and with TE.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 18 years, ability to hold breath during image acquisition, informed consent.
Exclusion Criteria:
* any condition that, in the investigator's clinical judgment, would make further participation in the study unacceptable for that individual patient.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
elastosonographic
Timeframe: up to 24 months
Trial details
NCT IDNCT07302152
SponsorFondazione IRCCS Policlinico San Matteo di Pavia