RecruitingNot ApplicableNCT04854317

Bariatric Endoscopy for Treatment of Obesity

Endoscopic Gastroplasty for Treatment of Obesity: a Single Centre, Randomized Trial

Sponsor

Mater Olbia Hospital

Enrollment

189 participants

Start Date

Jun 19, 2020

Study Type

INTERVENTIONAL

Conditions

Obesity

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

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 Criteria6

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.