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Clinical Trials in Brazil / NCT06785233
Recruiting Not applicable

Endoscopic Treatment of Overweight and Mild Obesity with ORBERA365

NCT06785233 · tracked via the Priya Life Science Brazil tracker
Sponsor
Kaiser Clinic and Hospital
Phase
Not applicable
Started
2025-01
Last updated
2025-01-21

Condition(s) studied

ObesityObesity, Morbid

Investigational drug(s) / intervention(s)

Non-Adjustable Intragastric BalloonORBERA365

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

ORBERA365: endoscopic treatment of overweight and mild obesity using a 12-month non-adjustable intragastric balloon

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Faculdade ABC Santo André São Paulo Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06785233 on ClinicalTrials.gov ↗ ← All trials in Brazil