Actively Recruiting
Endoscopic Ultrasound With Shear Wave Elastography for the Assessment of Liver Disease
Led by Olympus Corporation of the Americas · Updated on 2025-09-15
300
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of Endoscopic Ultrasound Shear Wave Elastography (EUS-SWE) and Attenuation Imaging (ATI) to assess liver fibrosis in patients with MASLD, MASH, and other chronic liver diseases. This prospective, multicenter, single-arm interventional study aims to establish optimal cutoffs for EUS-SWE compared to liver biopsy staging and evaluate its diagnostic performance against FibroScan and other non-invasive fibrosis screening tools. The study is designed as a post-market clinical registry enrolling eligible patients undergoing liver biopsy and ultrasound evaluations. Participants will undergo Endoscopic Ultrasound with Shear Wave Elastography and Attenuation Imaging, liver biopsy, and FibroScan. Liver biopsy and FibroScan should be performed within three months before or after the EUS procedure, with no significant weight change or bariatric surgery between tests. Up to 300 subjects will be enrolled across multiple U.S. sites, and all will be assigned unique study numbers. The study compares EUS-SWE and ATI results to liver biopsy pathology, FibroScan measurements (VCTE and CAP), and screening scores. During the study, participants will have their liver fibrosis and steatosis evaluated by these imaging and biopsy methods. Researchers will analyze data comparing EUS-SWE with biopsy staging and FibroScan results. The primary outcome focuses on how well EUS-SWE matches liver biopsy fibrosis staging. Secondary outcomes include correlations of EUS-SWE and ATI to fibrosis and steatosis scores. Study participation ends once pathology results are obtained, and the overall enrollment is expected to complete within 18 months.
CONDITIONS
Brief Title
Endoscopic Ultrasound Shear Wave Elastography Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Willing and able to provide informed consent
- Scheduled to undergo Endoscopic Ultrasound with liver biopsy, either in the same session or separately within three months
- Scheduled to undergo or have undergone FibroScan within three months of the Endoscopic Ultrasound
- No significant weight change (>10% total body weight) or bariatric surgery between procedures
- Body mass index (BMI) of 28 or higher
- Clinical suspicion of MASLD or MASH with or without fibrosis, based on non-invasive or minimally invasive methods
You will not qualify if you...
- Surgically altered anatomy preventing adequate ultrasound visualization of the liver
- Prior history of Hepatitis B or C infection
- Decompensated cirrhosis with complications such as gastrointestinal bleeding, ascites, or encephalopathy
- Presence of other chronic liver diseases confirmed by biopsy
- Inadequate liver biopsy samples
- History of or current excessive alcohol consumption (>140 g/week for females, >210 g/week for males) documented in medical records
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants undergo Endoscopic Ultrasound with Shear Wave Elastography and Attenuation Imaging, liver biopsy, and FibroScan to assess liver fibrosis and steatosis.
1 to 3 visits depending on scheduling of procedures
Duration - Until pathology results are obtained
Participants' pathology results from liver biopsy are reviewed to evaluate the effectiveness of the procedures in assessing liver disease.
1 visit (in-person) for results discussion
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Actively Recruiting
Research Team
O
Octavia Plingu
J
Jewel Gill
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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