Exploring the benefits of endoscopic procedures for obesity treatment
Endoscopic Weight Loss Therapy: Clinical Outcomes Over One Year of Follow-up
This study is testing if two new endoscopic procedures for weight loss can help people with obesity improve their weight, hormones, and overall quality of life over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05514288 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effects of endoscopic bariatric therapy, specifically endoscopic sleeve gastroplasty (ESG) and transoral outlet reduction (TORe), on weight loss, hormonal changes, and quality of life in patients over a 12-month period. Participants will undergo the chosen endobariatric procedure and receive behavioral interventions including diet and exercise therapy. Follow-up visits will be conducted to monitor progress and collect blood samples to assess hormonal profile changes. The study seeks to provide insights into the effectiveness of these minimally invasive procedures for obesity management.
Who should consider this trial
Good fit: Ideal candidates include adults with a BMI over 30 or over 27 with obesity-related comorbidities who are considering endoscopic bariatric therapy.
Not a fit: Patients with severe medical comorbidities or esophageal conditions that prevent endoscopic procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new effective treatment option for patients struggling with obesity.
How similar studies have performed: Previous studies have shown promising results with endoscopic bariatric procedures, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Angeles, California
- Liliana Bancila — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Kenneth Park, MD — Cedars-Sinai Medical Center
- Study coordinator: Liliana Bancila, PhD
- Email: Liliana.Bancila@cshs.org
- Phone: 310-423-3872
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.