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RECRUITINGINTERVENTIONAL

Benefits of Endoscopic Bariatric Procedures

Endoscopic Weight Loss Therapy: Clinical Outcomes Over One Year of Follow-up

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 willing to sign a consent form - Prior surgical or endoscopic anti-reflux procedure - Patients who are unwilling or unable to comply with the follow-up study schedule Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

PROCEDURE

Endobariatric procedure

Endoscopic sleeve gastroplasty or transoral outlet reduction

Locations (1)

Liliana Bancila
Los Angeles, California, United States