Endoscopic Ultrasound Shear Wave Elastography Study

NCT06592820 | Recruiting FDA Device

• 1 other identifier: 2021-GI-02
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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

MASLD; MASH; Fibrosis, Liver; Chronic Liver Disease

Keywords

Shear Wave Elastography; Shear Wave; FibroScan; Attenuation Imaging

Outcome Measures

Primary Outcomes (1)

• Shear Wave Elastography (SWE) vs liver biopsy METAVIR staging system

  Establish optimal cutoffs for EUS-SWE cutoffs in reference to liver biopsies on METAVIR staging system for significant fibrosis (F0-1 vs F2-4), advanced fibrosis (F0-2 vs F3-4), and cirrhosis (F0-3 vs F4) based on area under the receiver operator characteristics (AUROC) curve analysis.

  During study data analysis

Secondary Outcomes (3)

• SWE vs FibroScan and other non-invasive fibrosis screening modalities ( screening scores)

  During study analysis

• Correlation of EUS-SWE to fibrosis staging (from liver biopsy).

  During study analysis

• Correlation of EUS-ATI to steatosis score (from liver biopsy)

  During study analysis

Study Arms (1)

All subjects enrolled

Consecutive, eligible patients reporting for an endoscopic ultrasound liver biopsy and FibroScan for evaluation of liver fibrosis will be enrolled. EUS-SWE/ATI will be compared to liver biopsy pathology results, FibroScan (VCTE and CAP) results, and screening scores).

Device: Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging; Device: FibroScan; Device: Liver biopsy

Interventions

Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging DEVICE

EUS combines ultrasound technology with endoscopy to gain an internal vantage point to obtain higher resolution ultrasound images. Shear Wave is a software option on the ultrasound system EUS that provides an advanced measure and dynamic display of tissue stiffness which is being evaluated for use in assessing liver fibrosis. Attenuation Imaging (ATI) is a novel application that provides the capability to quantify and color-code the changes in attenuation coefficient of the liver that may arise with changes in liver composition (e.g., increased fat levels).

Also known as: EUS-SWE/ATI

All subjects enrolled

FibroScan DEVICE

A small ultrasound probe to measure the velocity of a sound wave passing through the liver. This is converted into kilopascals (kPa), which is used to assess liver fibrosis.

All subjects enrolled

Liver biopsy DEVICE

A biopsy of liver tissue could be obtained under endoscopic ultrasound guidance, interventional radiology (percutaneously), or surgically. Endoscopic Ultrasound-guided liver biopsy provides high resolution images of left lobe of the liver and a good portion of the right lobe of the liver. This, coupled with Doppler capability, allows the physician to direct the biopsy needle safely into the liver for sampling under real time image guidance.

Also known as: EUS-guided LB

All subjects enrolled

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic liver disease

You may qualify if:

• 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

Sponsors & Collaborators

• Olympus Corporation of the Americas: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Endosonography

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Marvin Ryou, MD

  Brigham and Women's Hospital, Boston, MA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Octavia Plingu

CONTACT

4089413623; octavia.plingu@olympus.com

Jewel Gill

CONTACT

9196333967; Jewel.Gill@olympus.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: September 19, 2024
• Study Start: September 3, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 28, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)