Comparing different filling volumes of intragastric balloons for obesity treatment
Fluid-filled Intragastric Balloon's Filling Volume At 500, 600, or 700 Ml for Treatment of Overweight and Obesity: Which is the Magic Number? a Single Centre Randomized Study
This study is testing which of three different sizes of intragastric balloons can help overweight and obese people lose weight safely and effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 156 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Mater Olbia Hospital Academic / other |
| Locations | 1 site (Olbia) |
| Trial ID | NCT06673550 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the efficacy and safety of three different filling volumes (500, 600, and 700 ml) of intragastric balloons in overweight and obese patients with a BMI between 27 and 60 kg/m2. Conducted at the Mater Olbia Hospital, the study involves a multidisciplinary team that evaluates patients before the procedure to ensure they are suitable candidates. The goal is to establish a well-defined filling volume for the intragastric balloon, as current practices vary without a clear rationale. The study is set to run from August 2022 to June 2025.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are classified as overweight or obese with a BMI between 27 and 60 kg/m2 and have at least one obesity-related comorbidity.
Not a fit: Patients with a history of bariatric surgery or endoscopy, allergies to methylene blue, or those who are pregnant or unwilling to comply with follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidelines for the optimal filling volume of intragastric balloons, potentially improving weight loss outcomes for patients.
How similar studies have performed: While there have been various studies on intragastric balloons, this specific comparison of filling volumes is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \> 18 years, obesity grade I-III, or overweight with at least one obesity-related comorbidity Exclusion Criteria: * history of bariatric surgery or endoscopy, allergies to methylene blue, childbearing or not willing to participate or comply with follow-up
Where this trial is running
Olbia
- Mater Olbia Hospital — Olbia, Italy (Recruiting)
Study contacts
- Principal investigator: Salvatore F Vadala di Prampero — Mater Olbia Hospital
- Study coordinator: Salvatore F Vadala di Prampero
- Email: vadaladiprampero@gmail.com
- Phone: 00393492666795
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.