Study of Endoscopic Ultrasound with Shear Wave Elastography to Assess Liver Fibrosis and Steatosis in Adults with Suspected MASLD or MASH

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.

Endoscopic Ultrasound Shear Wave Elastography Study