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Endoscopic Ultrasound Shear Wave Elastography Study

NCT06592820 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-09-15

No results posted yet for this study

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

Interventions

DEVICE

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).

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Olympus Corporation of the Americas

    lead INDUSTRY

Principal Investigators

  • Marvin Ryou, MD · Brigham and Women's Hospital, Boston, MA

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-03
Primary Completion
2027-02-28
Completion
2027-03-28
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06592820 on ClinicalTrials.gov