RecruitingNot ApplicableNCT05514288

Benefits of Endoscopic Bariatric Procedures

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

Sponsor

Cedars-Sinai Medical Center

Enrollment

20 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

Obesity

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

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 Criteria10

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