Status:
ACTIVE_NOT_RECRUITING
A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG)
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
American Society for Gastrointestinal Endoscopy
Boston Scientific Corporation
Conditions:
Non-alcoholic Steatohepatitis (NASH)
Endoscopic Sleeve Gastroplasty
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide. Affecting approximately one-third of the United States (U.S.) population, the prevalence of NAFLD increase...
Detailed Description
Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease worldwide. Affecting approximately one-third of the United States (U.S.) population, the prevalence of NAFLD increase...
Eligibility Criteria
Inclusion
- Patient is 18-65 years old
- Obesity (defined as BMI \> 30 kg/m2)
- Biopsy-proven NASH (defined as the presence of steatosis and hepatic injury in the form of ballooning or lobular inflammation)19
- Advanced fibrosis (defined as bridging fibrosis (F3) or cirrhosis (F4) on LB).
Exclusion
- Decompensated cirrhosis (defined as bleeding varices, ascites, encephalopathy and jaundice)
- gastric varices
- diabetes mellitus (defined as HbA1c ≥ 6.5%)
- active smoking
- being on an anticoagulant or anti-platelet medication
- active participation in any weight loss program, the use of a weight loss medication over the past 6 months and history of bariatric surgery or EBMT.
- Patients with esophageal varices are not excluded as long as they are on a non-selective beta-blocker for primary prophylaxis.
- Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study.
- Patient is unwilling or unable to sign and date the informed consent.
- Patient is unwilling or unable to comply with the follow-up study schedule.
- Patient for whom endoscopic procedures are contraindicated.
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04820036
Start Date
May 6 2021
End Date
December 24 2027
Last Update
December 2 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115