Endoscopic sleeve gastroplasty for obesity treatment
An Open-label, Randomized, Controlled Clinical Trial on the Effects of Endoscopic Sleeve Gastroplasty on Weight, Metabolic Risk Factors, Quality of Life, Satiety, Gastrointestinal Motility and Gut Microbiota
NA · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT04200144
This study is testing if a new procedure called endoscopic sleeve gastroplasty can help people with obesity lose weight and improve their health better than standard treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Locations | 1 site (Rome) |
| Trial ID | NCT04200144 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares the effects of endoscopic sleeve gastroplasty (ESG) on weight loss and metabolic health against standard medical therapy in individuals with obesity. Participants will be randomly assigned to either the ESG group or the control group, with follow-up assessments over 36 months. The study aims to evaluate various outcomes, including body weight loss, metabolic risk factors, quality of life, and changes in gut microbiota. Those in the control group may receive ESG after 6 months if they do not achieve satisfactory weight loss.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 to 65 with a BMI between 30 to 45 kg/m2 who are willing to comply with the study protocol.
Not a fit: Patients with active gastric ulcers, previous bariatric surgeries, or certain medical conditions such as uncontrolled thyroid disease or ongoing malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a minimally invasive option for significant weight loss and improved metabolic health in obese patients.
How similar studies have performed: Previous studies have shown promising results with endoscopic procedures for obesity, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The participants have to fulfill the following criteria for participating in the study: * Age 20 to 65 years * BMI between 30 to 45 kg/m2 * Willingness to participate in the study and ability to comply and understand the study protocol Exclusion Criteria: Active gastric ulcer during the last 6 months * Organic or motility disorder of the stomach and / or esophagus * Anticoagulant treatment * Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum * Ongoing or active malignancy during the last 5 years * Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification * Drug or alcohol abuse * Bulimic or binge eating pattern * Continuous glucocorticoid or anti-inflammatory treatment * Uncontrolled thyroid disease * Pregnancy, breastfeeding * Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study * Hiatal hernia \> 5 cm * Currently participating in other study * Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator
Where this trial is running
Rome
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Italy (RECRUITING)
Study contacts
- Study coordinator: Ivo Boskoski, MD, PhD
- Email: ivo.boskoski@policlinicogemelli.it
- Phone: +390630156580
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.
Conditions: Obesity, Endoscopic Sleeve Gastroplasty, Gastric Motility, Gastric Hormones, Microbiota, Quality of Life