Obalon in Children With Severe Obesity

Altered Liver Function Tests Clinical Trial

— Obalon  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137330
• Other study ID #: 539/RA
• Secondary ID: 539/RA Obalon
• Status: Completed
• Phase: Phase 3
• First received: May 7, 2014
• Last updated: July 21, 2015
• Start date: January 2014
• Est. completion date: June 2014

Study information

• Verified date: July 2015
• Source: Bambino Gesù Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Italian Agency for Durgs
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 17 Years

Eligibility

Inclusion Criteria:

• Weight > 97° pc -CDC BMI charts-

Exclusion Criteria:

• Prevous abdominal surgery

• Functional gastrointestinal motility disorders

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Swallowable Obalon® Gastric Balloon

Locations

Country	Name	City	State
Italy	Bambino Gesù Children Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Bambino Gesù Hospital and Research Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss (Kg)		3 months	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		3 months	No