Benefits of Endoscopic Bariatric Procedures
Recruiting · NCT05514288 · Interventional (participants receive a specific treatment) · Lead sponsor: Cedars-Sinai Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Endobariatric procedure
What this trial is 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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Liliana Bancila - Los Angeles, California, United States