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Clinical Trials in Italy / NCT04854317
Recruiting Not applicable

Bariatric Endoscopy for Treatment of Obesity

NCT04854317 · tracked via the Priya Life Science Italy tracker
Sponsor
Mater Olbia Hospital
Phase
Not applicable
Started
2020-06-19
Last updated
2025-02-03

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

Endoscopic gastroplasty

Endoscopic gastroplasty: Endoscopic Gastroplasty

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Mater Olbia Hospital Olbia Italy Recruiting

More Mater Olbia Hospital trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04854317 on ClinicalTrials.gov ↗ ← All trials in Italy