Endoscopic Ultrasound Shear Wave Elastography Study

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

NCT Number	NCT06592820
Lead Sponsor	Olympus Corporation of the Americas
Conditions	MASLD, MASH, Fibrosis, Liver, Chronic Liver Disease
Enrollment	300 participants
Start Date	2025-09-03
Primary Completion	2027-02-28 (estimated)
Study Completion	2027-03-28 (estimated)
Updated on ClinicalTrials.gov	2025-09-15