Status:
RECRUITING
Bariatric Endoscopy for Treatment of Obesity
Lead Sponsor:
Mater Olbia Hospital
Conditions:
Obesity
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 En...
Detailed Description
BACKROUND Obesity has reached epidemic proportions in the world affecting nowadays, along with overweight, over a third of the world's population. It is a chronic multifactorial illness that can lead ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT04854317
Start Date
June 19 2020
End Date
February 1 2025
Last Update
February 3 2025
Active Locations (1)
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1
Mater Olbia Hospital
Olbia, Italy, 07026