Comparing endoscopic techniques for treating obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the efficacy and safety of three endoscopic gastroplasty techniques in obese patients with a BMI between 30 and 44.99 kg/m2. The techniques being evaluated include Endoscopic Sleeve Gastroplasty, Endoluminal Vertical Gastroplasty, and Primary Obesity Surgery Endolumenal-2. Conducted at Mater Olbia Hospital, the trial will involve a randomized approach to assess outcomes over a period from June 2020 to August 2024. The study seeks to provide insights into less invasive options for obesity treatment, which may offer advantages over traditional surgical methods.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mater Olbia Hospital
  Olbia, Italy Recruiting

Study contacts

• Principal investigator: Salvatore F. Vadalà di Prampero, MD, PhD — Gastroenterology and GI Endoscopy
• Study coordinator: Salvatore F. Vadalà di Prampero, MD, PhD
• Email: vadaladiprampero@gmail.com
• Phone: 00393492666795

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.