Bariatric Endoscopy for Treatment of Obesity
Recruiting · NCT04854317 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Endoscopic gastroplasty
What this trial is about
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Mater Olbia Hospital - Olbia, Italy