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Endoscopic Treatment of Overweight and Mild Obesity with ORBERA365

RecruitingNAAges 18 Years - anyAllKaiser Clinic and Hospital
NCT06785233 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 implan

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📋 Eligibility rules (as published)
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.
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What it tests

  • Non-Adjustable Intragastric Balloon
  • ORBERA365
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Where

1 site
Faculdade ABC
Santo André, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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