Shear Wave Elastography Registry Study

Not yet recruiting

• Conditions: MASLD; MASH; Fibrosis, Liver; Chronic Liver Disease

• Registration Number: NCT06592820
• Lead Sponsor: Olympus Corporation of the Americas

Brief Summary

This study shall be a prospective, multicenter, single arm, consecutive, blinded, study conducted in a post-market setting using commercially available devices. Consecutive, eligible patients reporting for an ultrasound and liver biopsy for evaluation of fibrosis will be enrolled. EUS ShearWave Elastography technology will be compared to FibroScan. The data collected during this study will be evaluated in accordance with the procedures set forth in this protocol.

Detailed Description

A total of up to 300 subjects will be enrolled and treated at four US sites. Enrollment is expected to be completed within 18 months. Each subject will undergo both procedures (FibroScan and EUS with SW Elastography), End of study will be reached after pathology results have been obtained (within a week of the initial procedure).

This study has been designed as a post-market clinical registry to evaluate the effectiveness of Endoscopic Ultrasound with Shear Wave Elastography to estimate hepatic fibrosis in patients with chronic liver disease. All consenting, eligible patients reporting for an ultrasound and liver biopsy for evaluation of fibrosis meeting the inclusion criteria will be consecutively enrolled into the study and assigned a unique study identification number.

Study Timeline

• Study First Submitted: 2024-05-28
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-09
• Last Update Submitted: 2024-09-09
• Study First Posted: 2024-09-12
• Last Update Posted: 2024-09-12
• Study Start: 2025-01
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. 18 years of age or older
2. Willing and able to provide informed consent
3. 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
4. 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
5. BMI >/=28
6. 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)

Exclusion Criteria

1. Patients with surgically altered anatomy that precludes adequate endosonographic visualization of the liver parenchyma
2. Prior history of Hepatitis B or C infection
3. Decompensated cirrhosis (GI bleeding, ascites, encephalopathy)
4. Histological evidence of other concomitant chronic liver disease on biopsy
5. Inadequate liver biopsy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shear Wave Elastography (SWE) vs biopsy	After pathology results have been obtained (within a week of the initial procedure)	Correlation of SWE results relative to EUS guided liver biopsy results and establish cutoffs to predict fibrosis staging based on area under the curve analysis.

Secondary Outcome Measures

Name	Time	Method
SWE vs Fibroscan	Immediately after procedure	Evaluate the relative performance of SWE and Fibroscan in reference to fibrosis on liver biopsies.