Actively Recruiting
Endoscopic Ultrasound Shear Wave Elastography Study
Led by Olympus Corporation of the Americas · Updated on 2025-09-15
300
Participants Needed
2
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study shall be a prospective, multicenter, single arm, consecutive, interventional study conducted in a post-market setting using commercially available devices. Consecutive, eligible patients with clinical suspicion of MASLD or MASH reporting for an endoscopic ultrasound and liver biopsy for evaluation of fibrosis will be enrolled. EUS Shear Wave Elastography and Attenuation Imaging technologies will be compared to liver biopsy and FibroScan results and other non-invasive fibrosis screening modalities . The data collected during this study will be evaluated in accordance with the procedures set forth in the protocol. The main question\[s\] it aims to answer are: * Establish optimal cutoffs for EUS-SWE in reference to liver biopsies staging system for liver fibrosis * Evaluate the diagnostic performance of EUS-SWE compared to FibroScan (VCTE) and to other non-invasive fibrosis screening modalities (screening scores). Participants will undergo: * Endoscopic Ultrasound with Shear Wave Elastography (SWE) and Attenuation Imaging (ATI) * Liver biopsy * FibroScan
CONDITIONS
Official 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 EUS with liver biopsy, either same session or separately; if separate, biopsy must be within 3 months of EUS with no bariatric surgery or weight change >10%
- Scheduled to undergo or have undergone FibroScan within 3 months of EUS with no bariatric surgery or weight change >10%
- Body mass index (BMI) of 28 or higher
- Clinical suspicion of MASLD or MASH with or without fibrosis, determined by non-invasive methods like abdominal ultrasound or FibroScan
You will not qualify if you...
- Surgically altered anatomy preventing adequate liver visualization by endosonography
- Prior history of Hepatitis B or C infection
- Decompensated cirrhosis (such as GI bleeding, ascites, encephalopathy)
- Histological evidence of other chronic liver diseases on biopsy
- Inadequate liver biopsy sample
- Prior or current excessive alcohol consumption (>140 g/week for females, >210 g/week for males) documented in medical records
AI-Screening
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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
CONTACT
J
Jewel Gill
CONTACT
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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