Clinical trial

Endoscopic Treatment of Overweight and Mild Obesity with ORBERA365

Recruiting now · Not applicable · 1 countries · Registry ID NCT06785233

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionObesity, Obesity, Morbid

Full registry 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.

Treatments and study arms

Non-Adjustable Intragastric Balloon

Device

Weight Loss with a 12-Month Non-Adjustable Intragastric Balloon is More Effective Compared to a 6-Month Balloon.

ORBERA365

Device

endoscopic treatment of overweight and mild obesity using a 12-month non-adjustable intragastric balloon

Primary outcomes

Orbera365® intragastric balloon.12 weeks

Weight loss following the implantation of the Orbera365® intragastric balloon. Weight loss following the implantation of the Orbera365® intragastric balloon. Weight loss following the implantation of the Orbera365® intragastric balloon.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Faculdade ABC🇧🇷 Santo André, São Paulo, Brazil

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Eduardo GreccoContact

Email · Call +55 11 98162-0911