Status:
RECRUITING
Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial
Lead Sponsor:
Pichamol Jirapinyo, MD, MPH
Collaborating Sponsors:
Boston Scientific Corporation
Cook Group Incorporated
Conditions:
Obesity
Liver Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most pat...
Detailed Description
The National Institutes of Health, the World Health Organization, and numerous other scientific organizations including the America Medical Association (AMA) recognize obesity as a chronic disease req...
Eligibility Criteria
Inclusion
- Age ≥ 18 (male or female)
- BMI ≥30 kg/m2
- Self-reported stable weight (no weight change \>5%) for 6 months prior to the first study visit
- Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory/imaging/additional tests, and completing diet counseling
- Willingness to NOT start a new anti-obesity medication for the following 12 months
- Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete routine follow-up visits
- Ability to give informed consent
- Women of childbearing potential (i.e., not post-menopausal, nor surgically sterilized) must agree to use adequate birth control methods
Exclusion
- Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic)
- Treatment with vitamin E (at doses ≥800 IU/day), pioglitazone, obeticholic acid, or resmetirom \<90 days before the first study visit
- History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy)
- Prior bariatric surgery
- Prior endoscopic sleeve gastroplasty
- Any inflammatory disease of the GI tract, including severe (LA Grade C or D) esophagitis, Barrett's esophagus with dysplasia, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease
- Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses
- Severe gastroesophageal reflux disease (GERD)
- A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum, that could impede passage of the endoscope.
- Achalasia or any other severe esophageal motility disorder
- Chronic abdominal pain
- Gastroparesis or intractable constipation
- Hepatic insufficiency or cirrhosis
- Severe coagulopathy
- Insulin-dependent diabetes (either type 1 or type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or HgbA1C ≥ 10%
- Patients on an anti-platelet agent, anticoagulant agent or chronic/routine use of NSAIDs
- Patients on corticosteroids, immunosuppressants, or narcotics
- Patients on an anti-seizure or anti-arrhythmic medication
- Patients who are pregnant or breastfeeding
- Excessive alcohol consumption (\>20 g per day for women; \>30 g per day for men)
- Active smoking
- History of poorly controlled hypertension, coronary artery disease, congestive heart failure, cardiac arrhythmia
- History of respiratory diseases such as chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer
- History of autoimmune connective tissue disorder such as lupus, scleroderma or immunocompromised disease
- History of active malignancy
- History of genetic or hormonal causes for obesity, such as Prader Willi syndrome
- History of endocrine disorders affecting weight, such as uncontrolled hypothyroidism
- Eating disorders, including night eating syndrome, bulimia, binge eating disorder or compulsive overeating
- Active psychological issues preventing participation in a lifestyle modification program as determined by a psychologist
Key Trial Info
Start Date :
June 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06138821
Start Date
June 24 2025
End Date
June 1 2028
Last Update
December 2 2025
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
West Virginia University
Morgantown, West Virginia, United States, 26506