NCT05514288 Benefits of Endoscopic Bariatric Procedures
| NCT ID | NCT05514288 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cedars-Sinai Medical Center |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2025-09 |
Trial Parameters
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Brief Summary
This 12-months long pilot study will include patients undergoing an endoscopic procedure (endoscopic sleeve gastroplasty \[ESG\] or transoral outlet reduction \[TORe\]) as clinically indicated, and subsequent follow up clinic visits for up to one year.
Eligibility Criteria
Inclusion Criteria: * Patients who are considering undergoing EBT for weight loss * Patients with a BMI \>30 kg/m2 (without obesity related comorbidities) * Patients with a BMI \>27 kg/m2 (with obesity related comorbidities) * Patients willing and able to comply with study requirements for follow-up * Patients who previously underwent bariatric surgery who failed to lose the expected weight or regained weight * Individuals 18 years old or older are included Exclusion Criteria: * Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD) * Esophageal, gastric or duodenal malignancy * Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist * Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy * Known portal hypertension, vi
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