Benefits of Endoscopic Bariatric Procedures for Obesity

This study is looking at how well endoscopic bariatric procedures, specifically endoscopic sleeve gastroplasty (ESG) or transoral outlet reduction (TORe), help people with obesity lose weight. Researchers want to understand the effects of these procedures on weight changes, hormone levels, and quality of life. You might be able to join if you are between 18 and 75 years old, have a BMI (Body Mass Index) over 30, or a BMI over 27 with other health issues related to obesity. This study also includes people who had bariatric surgery before but didn't lose enough weight. The main goal is to see how much weight participants lose after these procedures over one year. The study is currently unclear on its recruitment status and plans to enroll 20 participants.

Study design
This is an interventional study with an unclear phase, planning to enroll 20 participants. It is a pilot study that will follow participants for up to one year.
What's involved
You would undergo an endoscopic bariatric procedure (ESG or TORe), participate in diet, exercise, and behavior modification, and have blood collected to check hormone changes. You would also have follow-up clinic visits for up to one year.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in body weight at 1 month, 3 months, 6 months, and 1 year after the procedure.

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NCT05514288

Benefits of Endoscopic Bariatric Procedures

Recruiting
NAAges 18–75InterventionalTreatment
Cedars-Sinai Medical Center
~20 participants
Updated 2024-08-26 on ClinicalTrials.gov
What's tested:Endobariatric procedure

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in body weight after various endoscopic bariatric therapies
Measured over Baseline/pre-procedure, 1 month, 3 months, 6 months, and 1 year post procedure
Obesity
1 sites across 1 states
California1
  • Kenneth Park, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

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Eligibility criteria

Inclusion

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

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
  • Changes in body weight after various endoscopic bariatric therapiesBaseline/pre-procedure, 1 month, 3 months, 6 months, and 1 year post procedure

    The investigators will compare mean percentage total body weight loss to baseline, at 1 month, 3 months, 6 months and 1 year post procedure.