Benefits of Endoscopic Bariatric Procedures

Cedars-Sinai Medical Center

Status

Enrolling

Conditions

Obesity

Treatments

Procedure: Endobariatric procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT05514288

STUDY00002145

Details and patient eligibility

About

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.

Full description

The purpose the research is to better understand the effects of endoscopic bariatric therapy (EBT) on the weight change, hormonal changes and changes in the quality of life parameters for patients undergoing endoscopic bariatric procedures.

The primary research procedures are:

EBT procedure (endoscopic sleeve gastroplasty [ESG] or transoral outlet reduction [TORe])
Behavioral intervention consisting of diet therapy, exercise therapy, and behavior modification
Collection of blood to evaluate changes in hormonal profiles

Enrollment

20 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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