Clinical Trial

Endoscopic Treatment of Overweight and Mild Obesity with ORBERA365

Study acronym: ORBERA365
Recruiting
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Summary
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.
Trial Details
NCT Number NCT06785233
Lead Sponsor Kaiser Clinic and Hospital
Conditions Obesity, Obesity, Morbid
Enrollment 30 participants
Start Date 2025-01
Primary Completion 2025-01 (estimated)
Study Completion 2026-02 (estimated)
Updated on ClinicalTrials.gov 2025-01-21