What is the Purpose of this Study?
The purpose of this study is to better understand the metabolic and hormonal effects of endoscopic bariatric therapy. Specifically, researchers will examine changes in weight, quality of life, and hormonal levels after various endoscopic bariatric therapies. Study procedures include endoscopic interventions (i.e., endoscopic sleeve gastroplasty), blood draw, medical record review, social worker interviews, dietician follow-ups, and clinical follow-up assessments. The study focuses on overweight/obese individuals who will receive an endoscopic bariatric procedure at Cedars-Sinai. The U.S. Food and Drug Administration has approved the EBT procedures as conducted in this study.
Eligibility
- * 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
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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, visible esophageal or gastric varices, or history of esophageal varices
- * General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation at the discretion of the investigator
- * Pregnant or planning to become pregnant during period of study participation
- * Patient refuses or is unable to provide written informed consent
- * Prior surgical or endoscopic anti-reflux procedure
- * Patients who are unwilling or unable to comply with the follow-up study schedule
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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Endoscopic Weight Loss Therapy: Clinical Outcomes Over One year of Follow-up