Recruiting

EUS-SHEAR Wave Elastography

Sponsor:

Olympus Corporation of the Americas

Code:

NCT06592820

Conditions

MASLD

MASH

Fibrosis, Liver

Chronic Liver Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging

FibroScan

Liver biopsy

Study Details

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

Study ID

NCT06592820

Start date

Sep 3, 2025

Status verified date

Sep, 2025

Completion date

Mar 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
6. Prior history of or current excess alcohol consumption (>140 g/week and >210 g/week for females and males, respectively) documented in EMR

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

Interventions

Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging

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).

FibroScan

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.

Liver biopsy

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.

Primary outcome measure

  • Shear Wave Elastography (SWE) vs liver biopsy METAVIR staging system [ Time Frame: During study data analysis ]

Central Contacts and Locations

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Marvin Ryou, MD

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Principal Investigator:

Khara Harshit, MD

More Information

Sponsor

Olympus Corporation of the Americas

Last update posted

Sep 15, 2025

Last verified

Sep, 2025

Keywords

  • Shear Wave Elastography
  • Shear Wave
  • FibroScan
  • Attenuation Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Olympus Corporation of the Americas on 2025-09-15.