NCT04854317 Bariatric Endoscopy for Treatment of Obesity
| NCT ID | NCT04854317 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mater Olbia Hospital |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 189 participants |
| Start Date | 2020-06-19 |
| Primary Completion | 2025-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 189 participants in total. It began in 2020-06-19 with a primary completion date of 2025-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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.
Contact & Investigator
Salvatore F. Vadalà di Prampero, MD, PhD
PRINCIPAL INVESTIGATOR
Gastroenterology and GI Endoscopy
Frequently Asked Questions
Who can join the NCT04854317 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04854317 currently recruiting?
Yes, NCT04854317 is actively recruiting participants. Contact the research team at vadaladiprampero@gmail.com for enrollment information.
Where is the NCT04854317 trial being conducted?
This trial is being conducted at Olbia, Italy.
Who is sponsoring the NCT04854317 clinical trial?
NCT04854317 is sponsored by Mater Olbia Hospital. The principal investigator is Salvatore F. Vadalà di Prampero, MD, PhD at Gastroenterology and GI Endoscopy. The trial plans to enroll 189 participants.
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