MASLDEUS-SWENCT06592820
Endoscopic Ultrasound Shear Wave Elastography Study
An observational study of MASLD and MASH, run by Olympus Corporation of the Americas at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MASLD, MASH, Fibrosis, Liver
- What is being tested?
- Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging, FibroScan and Liver biopsy
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Sep 2025to 28 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic liver disease
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Michele Ryan, MS, 617-676-5928, mryan@bwh.harvard.edu
Samantha Geltz, 843-290-4268, sgeltz@bwh.harvard.edu
- Recruiting
Geisinger Medical Center
Danville, Pennsylvania, 17822
Kali Rebuck, 570-214-1186, krebuck@geisinger.edu
Nikolas Antinnes, 5702141186, nantinnes@geisinger.edu
About this study
Official title: Endoscopic Ultrasound With Shear Wave Elastography for the Assessment of Liver Disease
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).
Read more
Participants will undergo:
- Endoscopic Ultrasound with Shear Wave Elastography (SWE) and Attenuation Imaging (ATI)
- Liver biopsy
- FibroScan
Read the detailed description
A total of up to 300 subjects will be enrolled and treated at up to six US sites. Enrollment is expected to be completed within 18 months. Each subject will undergo procedures (EUS with SW Elastography and Attenuation Imaging, liver biopsy and FibroScan). Liver biopsy and FibroScan should be done within three months from Endoscopic ultrasound with SWE and ATI. End of study participation for a subject will be reached after pathology results have been obtained.
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.
- Conditions
- MASLD, MASH, Fibrosis, Liver, Chronic Liver Disease
- Being tested
- Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging, FibroScan, Liver biopsy
- Keywords
- Shear Wave Elastography, Shear Wave, FibroScan, Attenuation Imaging
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation ImagingDevice
Also called EUS-SWE/ATI
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).
FibroScanDevice
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 biopsyDevice
Also called EUS-guided LB
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging; Device: FibroScan; Device: Liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During study data analysis
Secondary outcomes (3)
SWE vs FibroScan and other non-invasive fibrosis screening modalities ( screening scores)
Evaluate the diagnostic performance of EUS-SWE compared to FibroScan (VCTE) and to other non-invasive fibrosis screening modalities (e.g., Fibrosis-4 Score (FIB-4), AST to Platelet Ratio Index (APRI), and NAFLD Fibrosis Score (NFS)).
Measured: During study analysis
Correlation of EUS-SWE to fibrosis staging (from liver biopsy).
Evaluate the correlation of EUS-SWE to fibrosis staging (from liver biopsy).
Measured: During study analysis
Correlation of EUS-ATI to steatosis score (from liver biopsy)
Evaluate the correlation of EUS-ATI to steatosis score (from liver biopsy).
Measured: During study analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Sep 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olympus Corporation of the Americas
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marvin Ryou, MD, Principal investigator, Brigham and Women's Hospital, Boston, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592820
- Sponsor's protocol ID
- 2021-GI-02
- Acronym
- EUS-SWE
- Status last verified
- Sep 2025
- First submitted
- 28 May 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound With Shear Wave Elastography for the Assessment of Liver Disease
- ClinicalTrials.gov ID
- NCT06592820
- Acronym / sponsor ID
- EUS-SWE / 2021-GI-02
- Conditions
- MASLD, MASH, Fibrosis, Liver, Chronic Liver Disease
- Keywords
- Shear Wave Elastography, Shear Wave, FibroScan, Attenuation Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Olympus Corporation of the AmericasIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Mar 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
A total of up to 300 subjects will be enrolled and treated at up to six US sites. Enrollment is expected to be completed within 18 months. Each subject will undergo procedures (EUS with SW Elastography and Attenuation Imaging, liver biopsy and FibroScan). Liver biopsy and FibroScan should be done within three months from Endoscopic ultrasound with SWE and ATI. End of study participation for a subject will be reached after pathology results have been obtained.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects enrolled | – | Device: Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging, Device: FibroScan, Device: Liver biopsyConsecutive, 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic liver disease
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation ImagingAlso: EUS-SWE/ATIEUS 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 | All subjects enrolled |
| FibroScanA 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 | All subjects enrolled |
| Liver biopsyAlso: EUS-guided LBA 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. | Device | All subjects enrolled |
Primary outcome
Shear Wave Elastography (SWE) vs liver biopsy METAVIR staging system
Time frame: During study data analysis
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.
3 secondary outcomes
SWE vs FibroScan and other non-invasive fibrosis screening modalities ( screening scores)
Time frame: During study analysis
Correlation of EUS-SWE to fibrosis staging (from liver biopsy).
Time frame: During study analysis
Correlation of EUS-ATI to steatosis score (from liver biopsy)
Time frame: During study analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marvin Ryou, MD principal investigator
Brigham and Women's Hospital, Boston, MA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MASLD and MASH, run by Olympus Corporation of the Americas at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Octavia Plingu (4089413623, octavia.plingu@olympus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shear Wave Elastography (SWE) vs liver biopsy METAVIR staging system (time frame: During study data analysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025; AzTrials last refreshed its copy on 29 Oct 2026.