Benefits of Endoscopic Bariatric Procedures

Description

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.

Conditions

Obesity

Study Overview

Study Details

Study overview

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.

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

Benefits of Endoscopic Bariatric Procedures

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Liliana Bancila, Los Angeles, California, United States, 90048

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Cedars-Sinai Medical Center,

Kenneth Park, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

2025-09