Endoscopic treatment for overweight and mild obesity using Orbera365
Endoscopic Treatment of Overweight and Mild Obesity Using a 12-month Non-adjustable Intragastric Balloon (ORBERA365)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kaiser Clinic and Hospital Academic / other |
| Locations | 1 site (Santo André, São Paulo) |
| Trial ID | NCT06785233 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a BMI between 27 and 35 kg/m².
Not a fit: Patients with contraindications such as prior gastric surgery or significant esophageal conditions may not benefit from this treatment.
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 performed: Previous studies have shown positive outcomes with intragastric balloon treatments, indicating potential success for this approach.
Eligibility criteria
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 this trial is running
Santo André, São Paulo
- 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
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.