Obalon in Children With Severe Obesity

Phase 3

Completed

• Conditions: Severe Pediatric Obesity (BMI > 97° pc -According to Centers for Disease Control and Prevention BMI Charts-); Altered Liver Function Tests; Glycemic Intolerance
• Interventions: Device: Swallowable Obalon® Gastric Balloon

• Registration Number: NCT02137330
• Lead Sponsor: Bambino Gesù Hospital and Research Institute

Brief Summary

The ongoing global rise in the prevalence of overweight and obesity among all ages and among all ethnic groups, figures into a real epidemic phenomenon. This is accompanied by a higher incidence in serious health risks, already present at an early age, "switching-on" the engine towards obesity-related co-morbid diseases and morbid obesity. Weight loss is the only way to avoid systemic and cardiovascular complications of obesity.

Weight loss devices have been recently introduced in bariatric surgery, also in children. They mostly require invasive procedures to be applied. Mini-invasive devices would be needed to obtain weight loss in the pediatric population, since the early age of involved patients.

Obalon intragastric balloons, are swallowable devices. They are filled with liquid or air, and have been used to induce weight loss in obese adults. The investigators aimed to perform a pilot study in pediatrics, and monitor weight loss, metabolic and cardiovascular parameters modifications, after up-to-3 Obalon® Gastric Balloons placement.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-05
• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-05-09
• Study First Posted: 2014-05-13
• Study Completion: 2014-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-21
• Last Update Posted: 2015-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Weight > 97° pc -CDC BMI charts-

Exclusion Criteria

• Prevous abdominal surgery
• Functional gastrointestinal motility disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obalon Arm	Swallowable Obalon® Gastric Balloon	Children swalowed up to 3 intragastric balloons

Primary Outcome Measures

Name	Time	Method
Weight loss (Kg)	3 months

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	3 months

Trial Locations

Locations (1)

Bambino Gesù Children Hospital; 🇮🇹 Rome, Italy