Endoscopic Sleeve Gastroplasty for obesity treatment
Endoscopic Sleeve Gastroplasty / Endoscopic Sleeve Gastroplasty
This study is testing how well Endoscopic Sleeve Gastroplasty works for people with obesity by tracking their progress and health over a year while they receive regular medical care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Methodist Health System Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04640688 on ClinicalTrials.gov |
What this trial studies
This observational study involves a prospective registry of patients undergoing Endoscopic Sleeve Gastroplasty, a minimally invasive procedure aimed at treating obesity. Participants will receive standard medical care, including follow-up visits with healthcare providers and dietitians over the course of one year. Data will be collected from electronic health records to assess the safety and efficacy of the procedure. The study aims to evaluate outcomes based on routine clinical practices without additional research-related visits.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have a history of unsuccessful non-surgical weight-loss attempts and are willing to adhere to strict dietary guidelines post-procedure.
Not a fit: Patients under 18 years of age or those with prohibitive anesthetic risks may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could provide a new option for patients struggling with obesity who have not succeeded with traditional weight-loss methods.
How similar studies have performed: While the approach of Endoscopic Sleeve Gastroplasty is relatively novel, similar bariatric procedures have shown promising results in managing obesity.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Able to comprehend and provided written informed consent * Willing to comply with the substantial lifelong dietary restrictions required by the procedure * History of failure with non-surgical weight-loss methods * Willing to follow protocol requirements, including providing informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling * Women of childbearing potential ( not post-menopausal or surgically sterilized) must agree to use adequate birth control methods Exclusion Criteria: * Below 18 years of age * Prohibitive anesthetic risk
Where this trial is running
Dallas, Texas
- Methodist Dallas Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Prashant Kedia, MD — The Methodist Hospital Research Institute
- Study coordinator: Crystee Cooper, DHEd
- Email: clinicalresearch@mhd.com
- Phone: 214-947-1280
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.