Comparing different filling volumes of intragastric balloons for obesity treatment

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Optimized Flow for Obese Patients Undergoing Heart Surgery

  In this study, researchers will test whether using ideal body weight to set cardiopulmonary bypass flow during heart surgery helps obese adults see fewer transfusions and related complications.

  Recruiting Centre Hospitalier Universitaire, Amiens · Amiens · NCT07917494

• External Oblique Intercostal Block With or Without Lidocaine for Pain After Gastric Bypass

  This study tests whether adding a lidocaine IV infusion to a bilateral EOIB with low-dose fentanyl helps manage pain during gastric bypass in obese adults.

  Recruiting Menoufia University · Alexandria · NCT07809425

• Ketogenic (modified Atkins) diet for hypothalamic tumor–related central obesity

  This trial will try a modified Atkins ketogenic diet to help children and young adults with hypothalamic-chiasmatic tumors lose excess weight.

  Recruiting Meyer Children's Hospital IRCCS · Florence, Florence · NCT07396896

• Bariatric Surgery and Gut Microbiota Changes Over Time

  This study looks at how gut bacteria and stool metabolites change over 12 months after Roux-en-Y gastric bypass in adults with obesity, compared with those treated with diet alone and healthy-weight individuals.

  Recruiting Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Castellana Grotte, BA · NCT07381140

• KDS2010 for weight loss in adults with overweight or obesity

  This trial will test whether daily KDS2010 helps adults with overweight or obesity lose weight safely compared with a placebo.

  Recruiting at 3 sites Phase 2 NeuroBiogen Co., Ltd · Suwon, Gyeonggi-do and 2 other locations · NCT07009171

• Using adjustable headrests to improve breathing during painless surgery for overweight patients

  This study is testing if using adjustable headrests can help overweight patients breathe better and stay safe during painless surgery.

  Recruiting Maternal and Child Health Hospital of Hubei Province · Wuhan, Hubei · NCT06929000

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.