NCT06785233Recruiting
Endoscopic Treatment of Overweight and Mild Obesity with ORBERA365
Endoscopic Treatment of Overweight and Mild Obesity Using a 12-month Non-adjustable Intragastric Balloon (ORBERA365)
Source: ClinicalTrials.gov · Last updated 21 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
INTRODUCTION: Obesity is a critical health condition associated with high rates of morbidity and mortality. Conservative therapies such as dietary restriction, physical exercise, and pharmacological treatments have not prevented the rising incidence of obesity. Bariatric surgery, while effective, is limited to a relatively small proportion of the global obese population due to its strict indications and the risk of early and late postoperative complications. To address this gap, bariatric endoscopy therapies have emerged, offering less invasive, reversible, repeatable, and more cost-effective treatment options. The introduction of the intragastric balloon (IGB) in the 1980s marked the development of a minimally invasive, non-surgical, and safe procedure with low complication rates. OBJECTIVE: To evaluate the weight loss efficacy in overweight and Class I obese patients through the implantation of a 12-month non-adjustable intragastric balloon. METHODS: This prospective study involved overweight patients (BMI \> 27 kg/m²) undergoing intragastric balloon treatment and multidisciplinary follow-up at the Bariatric Endoscopy Clinic of the Faculty of Medicine of ABC (FMABC) over a 12-month period. EXPECTED RESULTS: Weight loss following intragastric balloon implantation and improvement in metabolic indices.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 9 Jan 2025
- Start date
- Jan 2025
- Primary completion date
- Jan 2025
- Lead sponsor
- Kaiser Clinic and Hospital
- Diseases
- Obesity
- NCT number
- NCT06785233
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Jan 2025 to the primary completion date, Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- prior gastric surgery,
- substance dependence (alcohol or illicit drugs),
- continuous anticoagulant or anti-inflammatory therapy, and those with
Other illness
- peptic ulcer,
Other
- Relative or absolute contraindications for this procedure, such as hiatal hernia (\> 3 cm),
- Los Angeles grade erosive esophagitis,
- positive urease test results until treatment is completed and evidence of resolution is provided or follow-up is lost.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculdade ABC Coordinator of this site? Confirm its status | Santo André | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.