Endoscopic Ultrasound Shear Wave Elastography Study

Recruiting now

Conditions studied: MASLD, MASH, Fibrosis, Liver, Chronic Liver Disease

In brief

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

Key facts

Study ID: NCT06592820
Run by: Olympus Corporation of the Americas
People needed: 300
Starts: 2025-09-03
Expected to finish: 2027-03-28
Last updated by the study team: 2025-09-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

18 years of age or older
Willing and able to provide informed consent
Patient scheduled to undergo EUS with liver biopsy, either same session or separately; if separate, liver biopsy should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure/surgery or weight change of >10% total body weight
Patient scheduled to undergo or have undergone FibroScan, which should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure/surgery or weight change of >10% total body weight
BMI >/=28
Clinical suspicion of MASLD (hepatic steatosis with at least one of five cardiometabolic risk factors: 1) overweight or obesity, 2) elevated glucose, 3) low HDL-C, 4) hypertension, and/or 5) hypertriglyceridemia) or MASH (additionally characterized by the presence of inflammation and hepatocellular ballooning) with or without fibrosis, as determined by non-invasive or minimally invasive techniques (e.g. abdominal ultrasound, FibroScan)

You may not qualify if…

Patients with surgically altered anatomy that precludes adequate endosonographic visualization of the liver parenchyma
Prior history of Hepatitis B or C infection
Decompensated cirrhosis (GI bleeding, ascites, encephalopathy)
Histological evidence of other concomitant chronic liver disease on biopsy
Inadequate liver biopsy
Prior history of or current excess alcohol consumption (>140 g/week and >210 g/week for females and males, respectively) documented in EMR

Where it is running

Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
Geisinger Medical Center — Danville, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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