Benefits of Endoscopic Bariatric Procedures
- Conditions
- Obesity
- Registration Number
- NCT05514288
- Lead Sponsor
- Cedars-Sinai Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Patients who are considering undergoing EBT for weight loss<br><br> - Patients with a BMI >30 kg/m2 (without obesity related comorbidities)<br><br> - Patients with a BMI >27 kg/m2 (with obesity related comorbidities)<br><br> - Patients willing and able to comply with study requirements for follow-up<br><br> - Patients who previously underwent bariatric surgery who failed to lose the expected<br> weight or regained weight<br><br> - Individuals 18 years old or older are included<br><br>Exclusion Criteria:<br><br> - Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope<br> during screening/baseline Esophagogastroduodenoscopy (EGD)<br><br> - Esophageal, gastric or duodenal malignancy<br><br> - Severe medical comorbidities precluding endoscopy, or limiting life expectancy to<br> less than 2 years in the judgment of the endoscopist<br><br> - Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet<br> medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy<br><br> - Known portal hypertension, visible esophageal or gastric varices, or history of<br> esophageal varices<br><br> - General poor health, multiple co-morbidities placing the patient at risk, or<br> otherwise unsuitable for trial participation at the discretion of the investigator<br><br> - Pregnant or planning to become pregnant during period of study participation<br><br> - Patient refuses or is unable to provide written informed consent<br><br> - Prior surgical or endoscopic anti-reflux procedure<br><br> - Patients who are unwilling or unable to comply with the follow-up study schedule
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in body weight after various endoscopic bariatric therapies
- Secondary Outcome Measures
Name Time Method Changes in hormonal profiles after various endoscopic bariatric therapies