NCT04854317Recruiting
Bariatric Endoscopy for Treatment of Obesity
Endoscopic Gastroplasty for Treatment of Obesity: a Single Centre, Randomized Trial
Source: ClinicalTrials.gov · Last updated 3 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
A single-center, randomized trial will be conducted in order to compare three Endoscopic Gastroplasty (EG) techniques in obese patients (BMI 30-44.99 kg/m2) at Gastroenterology and Gastrointestinal Endoscopy Unit, Mater Olbia Hospital, Qatar Foundation Endowment \& Gemelli Foundation, Italy in period June 2020 - August 2024, with the aim to compare the efficacy and safety of these procedures.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 189 (estimated)
- First submitted
- 1 Apr 2021
- Start date
- 19 Jun 2020
- Primary completion date
- Feb 2025
- Lead sponsor
- Mater Olbia Hospital
- Diseases
- Obesity
- NCT number
- NCT04854317
What you commit to
- Study type: Interventional
- Planned participants: 189
- From 19 Jun 2020 to the primary completion date, Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- patients who underwent previous attempts at surgical or endoscopic bariatric therapy;
Other illness
- patients suffering from any condition which precludes compliance with study instructions;
- patient has any allergy or other known contraindication or intolerance to the medications used in the study;
- patient suffers from a life threatening condition.
Other
- 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;
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mater Olbia Hospital Coordinator of this site? Confirm its status | Olbia | Italy | Recruiting |
Related publications
- Effects of different techniques of endoscopic gastroplasty on weight loss among patients with obesity: a randomized, single-center pragmatic trial.Gastrointest Endosc · 2026 · PMID 41456751
This page is information, not medical advice. Discuss any trial with your doctor.