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Obalon in Children With Severe Obesity (Obalon)

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Swallowable Obalon® Gastric Balloon
Sponsored by
Bambino Gesù Hospital and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Pediatric Obesity (BMI > 97° pc -According to Centers for Disease Control and Prevention BMI Charts-) focused on measuring Obalon swallowable intragastric balloons, Severe obesity, Children

Eligibility Criteria

9 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Weight > 97° pc -CDC BMI charts-

Exclusion Criteria:

  • Prevous abdominal surgery
  • Functional gastrointestinal motility disorders

Sites / Locations

  • Bambino Gesù Children Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Obalon Arm

Dietary and lifestyle changes Arm

Arm Description

Children swalowed up to 3 intragastric balloons

Outcomes

Primary Outcome Measures

Weight loss (Kg)

Secondary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Full Information

First Posted
May 7, 2014
Last Updated
July 21, 2015
Sponsor
Bambino Gesù Hospital and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02137330
Brief Title
Obalon in Children With Severe Obesity
Acronym
Obalon
Official Title
Tolerance and Efficacy of the Swallowable Obalon® Gastric Balloons System in Children With Severe Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bambino Gesù Hospital and Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Pediatric Obesity (BMI > 97° pc -According to Centers for Disease Control and Prevention BMI Charts-), Altered Liver Function Tests, Glycemic Intolerance
Keywords
Obalon swallowable intragastric balloons, Severe obesity, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obalon Arm
Arm Type
Experimental
Arm Description
Children swalowed up to 3 intragastric balloons
Arm Title
Dietary and lifestyle changes Arm
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Swallowable Obalon® Gastric Balloon
Primary Outcome Measure Information:
Title
Weight loss (Kg)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Weight > 97° pc -CDC BMI charts- Exclusion Criteria: Prevous abdominal surgery Functional gastrointestinal motility disorders
Facility Information:
Facility Name
Bambino Gesù Children Hospital
City
Rome
ZIP/Postal Code
00100
Country
Italy

12. IPD Sharing Statement

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Obalon in Children With Severe Obesity

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