Benefits of Endoscopic Bariatric Procedures

Last updated: August 23, 2024
Sponsor: Cedars-Sinai Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

Endobariatric procedure

Clinical Study ID

NCT05514288
STUDY00002145
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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 expectedweight or regained weight

  • Individuals 18 years old or older are included

Exclusion

Exclusion Criteria:

  • Pre-existing esophageal stenosis/stricture preventing advancement of an endoscopeduring screening/baseline Esophagogastroduodenoscopy (EGD)

  • Esophageal, gastric or duodenal malignancy

  • Severe medical comorbidities precluding endoscopy, or limiting life expectancy toless than 2 years in the judgment of the endoscopist

  • Uncontrolled coagulopathy or inability to be off anticoagulation or anti-plateletmedication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy

  • Known portal hypertension, visible esophageal or gastric varices, or history ofesophageal varices

  • General poor health, multiple co-morbidities placing the patient at risk, orotherwise 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

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Endobariatric procedure
Phase:
Study Start date:
November 01, 2022
Estimated Completion Date:
September 30, 2025

Study 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

Connect with a study center

  • Liliana Bancila

    Los Angeles, California 90048
    United States

    Active - Recruiting

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