Comparing endoscopic techniques for treating obesity
Endoscopic Gastroplasty for Treatment of Obesity: a Single Centre, Randomized Trial
This study is testing three different endoscopic methods to see which one works best and is safest for people with obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 189 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Mater Olbia Hospital Academic / other |
| Locations | 1 site (Olbia) |
| Trial ID | NCT04854317 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the efficacy and safety of three endoscopic gastroplasty techniques in obese patients with a BMI between 30 and 44.99 kg/m2. The techniques being evaluated include Endoscopic Sleeve Gastroplasty, Endoluminal Vertical Gastroplasty, and Primary Obesity Surgery Endolumenal-2. Conducted at Mater Olbia Hospital, the trial will involve a randomized approach to assess outcomes over a period from June 2020 to August 2024. The study seeks to provide insights into less invasive options for obesity treatment, which may offer advantages over traditional surgical methods.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged over 18 with a BMI between 30 and 44.99 kg/m2 who have previously attempted weight loss through diet without success.
Not a fit: Patients who have undergone previous surgical or endoscopic bariatric therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with safer and more effective options for weight loss through less invasive procedures.
How similar studies have performed: Other studies have shown promise with similar endoscopic approaches for obesity treatment, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \> 18 years old; * acceptance of written informed consent to undergo an EG; * capability to understand and comply with the study protocol; * obesity: a BMI of 30-34.99 kg/m2 with previous failed attempts at diet and with obesity-related diseases, a BMI of 35-39.99 kg/m2 with previous failed attempts at diet and with or without obesity-related diseases, a BMI of 40-44.99 kg/m2 with previous failed attempts at diet and with or without obesity-related diseases not fit for surgery. Exclusion Criteria: * patients who do not give their consent to the enrollment in the study or are incompetent, unconscious or unable to express their consent for any reason; * patients suffering from any condition which precludes compliance with study instructions; * patients who underwent previous attempts at surgical or endoscopic bariatric therapy; * patient has any allergy or other known contraindication or intolerance to the medications used in the study; * women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice methods of contraception; * patient suffers from a life threatening condition.
Where this trial is running
Olbia
- Mater Olbia Hospital — Olbia, Italy (Recruiting)
Study contacts
- Principal investigator: Salvatore F. Vadalà di Prampero, MD, PhD — Gastroenterology and GI Endoscopy
- Study coordinator: Salvatore F. Vadalà di Prampero, MD, PhD
- Email: vadaladiprampero@gmail.com
- Phone: 00393492666795
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.