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New treatment option for Obesity
Official title Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06138821
What this study is testing
- What it's testing
- 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 patients regain weight limiting ultimate improvement in liver disease.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 (male or female)
- BMI ≥30 kg/m2 or ≥27 kg/m2 with at least one obesity-related comorbidity
- 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...
- Willingness to NOT start a new anti-obesity medication for the following 12 months
You likely can't join if
- 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...
See the full eligibility criteria
- Age ≥ 18 (male or female)
- BMI ≥30 kg/m2 or ≥27 kg/m2 with at least one obesity-related comorbidity
- 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
- 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...
- 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...
- 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 ≥ 12%
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Morgantown, West Virginia, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Morgantown, West Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.