Status:
RECRUITING
Endoscopic Ultrasound Shear Wave Elastography Study
Lead Sponsor:
Olympus Corporation of the Americas
Conditions:
MASLD
MASH
Eligibility:
All Genders
18+ years
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 wi...
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 Elastograph...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
September 3 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 28 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06592820
Start Date
September 3 2025
End Date
March 28 2027
Last Update
September 15 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822