NCT06785233

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 21, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 21, 2025

Status Verified

January 1, 2025

Enrollment Period

Same day

First QC Date

January 9, 2025

Last Update Submit

January 17, 2025

Conditions

ObesityObesity, Morbid

Keywords

obesityIntragastric Balloon

Outcome Measures

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.

    12 weeks

Study Arms (1)

Intragastric Ballon

EXPERIMENTAL

Endoscopic placement of Orbera365® non-adjustable intragastric balloon under general anesthesia. Device filled with 600mL saline solution with methylene blue, remaining in situ for 12 months. Weekly follow-up in first month, then monthly visits including nutritional and psychological support. Removal performed under general anesthesia after 12-month period.

Device: Non-Adjustable Intragastric BalloonDevice: ORBERA365

Interventions

Non-Adjustable Intragastric BalloonDEVICE

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

Intragastric Ballon
ORBERA365DEVICE

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

Also known as: Intragastric Balloon
Intragastric Ballon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade ABC

Santo André, São Paulo, 09060-870, Brazil

RECRUITING

MeSH Terms

Conditions

ObesityObesity, Morbid

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Roberto Luiiz Kaiser Junior

    Kaiser Clinica

    STUDY CHAIR

Central Study Contacts

Luiz Gustavo de Quadros LGQ Quadros, Doutor

CONTACT

+55 17 98138-8737gustavo_quadros@hotmail.com

Manoel Galvão Neto

CONTACT

+55 (11) 97797.0239

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: endoscopic treatment of overweight and mild obesity using a 12-month non-adjustable intragastric balloon
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2025

First Posted

January 21, 2025

Study Start

January 1, 2025

Primary Completion

January 1, 2025

Study Completion

February 1, 2026

Last Updated

January 21, 2025

Record last verified: 2025-01

Locations

BR(1)