Benefits of Endoscopic Bariatric Procedures

Launched by CEDARS-SINAI MEDICAL CENTER · Aug 22, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the benefits of two endoscopic procedures, called endoscopic sleeve gastroplasty (ESG) and transoral outlet reduction (TORe), to help people lose weight. The study will last for 12 months and will include individuals who are considering these procedures for weight loss. Eligible participants are typically adults aged 18 and older with a body mass index (BMI) over 30, or over 27 if they have weight-related health issues. The trial is currently recruiting and aims to learn more about how effective these procedures are for different patients.

If you decide to participate, you can expect to undergo one of the endoscopic procedures and then have follow-up visits over the next year to monitor your progress. It's important to be able to keep these follow-up appointments and to provide informed consent to join the study. However, certain health conditions or previous surgeries may prevent someone from participating, so discussing your specific situation with the study team is crucial. Overall, this trial aims to gather valuable information to help improve weight loss treatments for people struggling with obesity.

Gender

ALL

Eligibility criteria

• 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