Endoscopic Treatment of Overweight and Mild Obesity with ORBERA365

Recruiting now · Not applicable

Conditions studied: Obesity, Obesity, Morbid

In brief

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.

Key facts

Study ID: NCT06785233
Run by: Kaiser Clinic and Hospital
People needed: 30
Starts: 2025-01-01
Expected to finish: 2026-02-01
Last updated by the study team: 2025-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Faculdade ABC — Santo André, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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