Bariatric Endoscopy for Treatment of Obesity
ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMater Olbia Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Endoscopic gastroplasty
Treatment groups
189 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov