NCT02137330

Obalon in Children With Severe Obesity

Tolerance and Efficacy of the Swallowable Obalon® Gastric Balloons System in Children With Severe Obesity

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Bambino Gesù Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 9 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Pediatric Obesity (BMI > 97° pc -According to Centers for Disease Control and Prevention BMI Charts-)
• Altered Liver Function Tests
• Glycemic Intolerance

Interventions

Type	Name	Description
DEVICE	Swallowable Obalon® Gastric Balloon

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-05-01
• Completion: 2014-06-01
• First posted: 2014-05-13
• Last updated: 2015-07-22

Locations

1 site across 1 country: Italy