NCT05728697Recruiting
Endoscopic Ultrasound Shear Wave Elastography in Patients With Non-alcoholic Fatty Liver Disease
Endoscopic Ultrasound Shear Wave Elastography: A Novel Tool for Fibrosis Screening in Patient With Elevated Body Mass Index and Suspected Non-Alcoholic Fatty Liver Disease or Steatohepatitis
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
The goal of this observation study is to assess whether endoscopic ultrasound shear wave elastography (EUS-SWE) may be a useful tool for liver fibrosis screening in patients with elevated body mass index and non alcoholic fatty liver disease as compared to other non-invasive screening modalities, which have traditionally had less accurate results in this population. The main questions it aims to answer are: * Determine accuracy of EUS-SWE for liver fibrosis screening compared to other non-invasive scoring systems, such as the FIB-4 score and Fibroscan in patients with elevated body mass index * Establish optimal stiffness (kPa) cutoffs for liver fibrosis grading for EUS-SWE for this patient population in reference to the gold standard liver biopsy, as no standard cutoffs currently exist. Participants will undergo routine endoscopic ultrasound as part of their standard clinical care and indication. Participants are consented for the procedure and undergoing the shear wave elastography. In addition to their standard ultrasound test, it takes on average an extra 2-3 minutes to perform the shear wave elastography. The procedure itself adds no additional risk to the patient and does not expose them to radiation.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 18 Jan 2023
- Start date
- 1 Jun 2021
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05728697
What you commit to
- Study type: Observational
- Planned participants: 150
- From 1 Jun 2021 to the primary completion date, 31 Oct 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Inadequate liver biopsy sample
Who the study is looking for
- Adults 18 years or older
- Planned for clinically indicated endoscopic ultrasound with plan for follow up liver biopsy
- Suspected or confirmed non alcoholic fatty liver disease prior to procedure
- Body mass index \>=25
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Faulkner Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.