Clinical trial
Bariatric Endoscopy for Treatment of Obesity
Recruiting now · Not applicable · 1 countries · Registry ID NCT04854317
Recruiting nowNot applicableInterventional
What this study 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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity
Full registry 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.
Treatments and study arms
Endoscopic gastroplasty
Procedure
Endoscopic Gastroplasty
Primary outcomes
Percentage of Total Body Weight Loss (TBWL percent)at 30±15, 90±30, 180±30, 360±30, 540±30 days after the procedure
To evaluate the percentage of Total Body Weight Loss after each endoscopic bariatric procedure
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Mater Olbia Hospital🇮🇹 Olbia, Italy
Salvatore F. Vadalà di Prampero, MD, PhdContact