Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06785233

Endoscopic Treatment of Overweight and Mild Obesity with ORBERA365

Led by Kaiser Clinic and Hospital · Updated on 2025-01-21

30

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Endoscopic Treatment of Overweight and Mild Obesity with ORBERA365

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants with a Body Mass Index (BMI) above 27 kg/m8
  • Both sexes
  • Aged 18 years or older
  • Consent to participate by signing an Informed Consent Form
  • Agree to have the Orbera365 balloon implanted at Kaiser Clinic or FMABC/Hospital Mario Covas
Not Eligible

You will not qualify if you...

  • Hiatal hernia larger than 3 cm
  • Los Angeles grade erosive esophagitis
  • Peptic ulcer
  • Prior gastric surgery
  • Substance dependence (alcohol or illicit drugs)
  • Continuous anticoagulant or anti-inflammatory therapy
  • Positive urease test until treatment completion or lost follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Faculdade ABC

Santo André, São Paulo, Brazil, 09060-870

Actively Recruiting

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Research Team

L

Luiz Gustavo de Quadros LGQ Quadros, Doutor

CONTACT

M

Manoel Galvão Neto

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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