Endoscopic treatment for overweight and mild obesity using Orbera365
Official title: Endoscopic Treatment of Overweight and Mild Obesity Using a 12-month Non-adjustable Intragastric Balloon (ORBERA365)
Run by Kaiser Clinic and Hospital · NCT06785233 · Data updated 2026-11-12
This study is testing whether the Orbera365 intragastric balloon can help people who are overweight or mildly obese lose weight over a year.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Kaiser Clinic and Hospital Academic / other |
| Locations | 1 site (Santo André, São Paulo) |
| Status | Recruiting |
| Started | January 2025 |
| Main results expected | January 2025 |
| Study ends | February 2026 |
| Registry record updated | January 21, 2025 |
| Trial ID | NCT06785233 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a BMI between 27 and 35 kg/m².
✕Probably not a fit
Patients with contraindications such as prior gastric surgery or significant esophageal conditions may not benefit from this treatment.
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 evaluates the effectiveness of the Orbera365 non-adjustable intragastric balloon for weight loss in patients with overweight and Class I obesity. Participants with a BMI over 27 kg/m² will undergo the implantation of the balloon, which is designed to be a minimally invasive and reversible procedure. The study will collect demographic, clinical, and operative data to assess the outcomes of the treatment over a 12-month period. The procedures will be conducted at two locations in São Paulo, Brazil.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for weight loss in patients struggling with obesity.
How similar studies have gone: Previous studies have shown positive outcomes with intragastric balloon treatments, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants with a Body Mass Index (BMI) above 27 kg/m², * both sexes, * aged 18 years or older, * who consent to their participation by signing an Informed Consent Form and * agree to the implantation of the Orbera365® balloon at Kaiser Clinic and the Faculty of Medicine of ABC (FMABC)/Hospital Mario Covas. Exclusion Criteria: * Relative or absolute contraindications for this procedure, such as hiatal hernia (\> 3 cm), * Los Angeles grade erosive esophagitis, * peptic ulcer, * prior gastric surgery, * substance dependence (alcohol or illicit drugs), * continuous anticoagulant or anti-inflammatory therapy, and those with * positive urease test results until treatment is completed and evidence of resolution is provided or follow-up is lost.
Where it's running
-
Faculdade ABC
Santo André, São Paulo, Brazil Recruiting
Study contacts
- Study coordinator: Luiz Gustavo de Quadros LGQ Quadros, Doutor
- Email: gustavo_quadros@hotmail.com
- Phone: +55 17 98138-8737
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Adding naltrexone–bupropion extended‑release to sleeve gastrectomy to improve weight loss
This trial will test whether taking naltrexone–bupropion extended‑release after sleeve gastrectomy helps adults with obesity lose more weight and improve related health problems.
-
Using a new endoscopy technique for bariatric patients
This study is testing a new, less invasive endoscopy method for bariatric patients to see if it can improve safety and reduce costs when checking for stomach and digestive issues.
-
Endoscopic Antral Myotomy for Weight Loss
This study is testing a new weight loss procedure called Pylorus Sparing Antral Myotomy to see if it helps people with obesity lose weight safely and effectively on its own.
-
Improving outcomes for patients with failed sleeve gastrectomy using a new surgical approach
This study is testing a new type of surgery called SADI-S to see if it can help people who didn't have success with their previous sleeve gastrectomy lose weight and improve their health.
-
Ocular Changes in People Using Tirzepatide or Semaglutide
This study checks whether eye structure and blood vessels change in adults with obesity who are taking semaglutide or tirzepatide as part of routine care.
-
Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes
This study tests whether eight weeks of supervised whole-body vibration training changes ankle muscle activity and walking performance in women with obesity, comparing those with and without type 2 diabetes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.