Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Faculdade ABC
Santo André, São Paulo, Brazil, 09060-870
Actively Recruiting
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here