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Search / Trial NCT04854317

Bariatric Endoscopy for Treatment of Obesity

Launched by MATER OLBIA HOSPITAL · Apr 17, 2021

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

Weight Obese Endoscopic Sleeve Gastroplasty Endoluminal Vertical Gastroplasty Primary Obesity Surgical Endolumenal 2

ClinConnect Summary

This clinical trial is looking at different techniques for a procedure called Endoscopic Gastroplasty (EG) to help people who are struggling with obesity. Specifically, it will compare three different EG methods to see how effective and safe they are for patients with a body mass index (BMI) between 30 and 44.99 kg/m². The trial is taking place at the Gastroenterology and Gastrointestinal Endoscopy Unit in Qatar from June 2020 to August 2024, and they are currently recruiting participants.

To be eligible for the study, participants must be at least 18 years old, have a BMI in the specified range, and have previously tried losing weight through diet without success. They should also be willing to give informed consent and be able to follow the study's guidelines. Participants can expect to undergo one of the EG techniques and will be closely monitored throughout the process for safety and effectiveness. It's important to note that individuals with certain medical conditions or who have had previous bariatric procedures may not qualify for the study. This trial is a unique opportunity to explore new treatments for obesity and may help improve outcomes for those involved.

Gender

ALL

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.

About Mater Olbia Hospital

Mater Olbia Hospital is a leading healthcare institution dedicated to providing high-quality medical services and advancing clinical research. Located in Olbia, Italy, the hospital is equipped with state-of-the-art facilities and a team of highly qualified professionals committed to patient care and innovative treatments. As a clinical trial sponsor, Mater Olbia Hospital emphasizes the importance of rigorous scientific protocols and ethical standards, aiming to contribute valuable insights to the medical community and improve patient outcomes through evidence-based practices. The hospital collaborates with various stakeholders to facilitate research that addresses critical health challenges, fostering a culture of excellence in clinical research.

Locations

Olbia, , Italy

Patients applied

0 patients applied

Trial Officials

Salvatore F. Vadalà di Prampero, MD, PhD

Principal Investigator

Gastroenterology and GI Endoscopy

Milutin Bulajic, MD, PhD

Study Chair

Gastroenterology and GI Endoscopy

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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