Endoscopic Treatment of Overweight and Mild Obesity with ORBERA365

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKaiser Clinic and Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Relative or absolute contraindications for this procedure, such as hiatal hernia (> 3 cm),

Los Angeles grade erosive esophagitis,

peptic ulcer,

prior gastric surgery,

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Intragastric BallonExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Orbera365® intragastric balloon.

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.

Time frame
12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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