Benefits of Endoscopic Bariatric Procedures

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

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

Conditions2

Locations1 site

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