Obalon in Children With Severe Obesity | NCT02137330

Studies
Obalon in Children With Severe Obesity

NCT02137330

Sponsor

Bambino Gesù Hospital and Research Institute

Status

Completed

Last Update Posted

Jul 22, 2015Estimated

Enrollment

10Actual

Phase

Phase 3

Conditions

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

Interventions

Swallowable Obalon® Gastric Balloon

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
539/RA Obalon	Registry Identifier	539/RA, Ethical Commette of Bambino Gesù Children Hospital, Vatican City

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

May 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

May 7, 2014

First Submission Date that Met QC Criteria

May 9, 2014

First Posted Date

May 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2015

Last Update Posted Date

Jul 22, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Valerio Nobili, MD, Bambino Gesù Hospital and Research InstitutePrincipal Investigator

Lead Sponsor

Bambino Gesù Hospital and Research InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Obalon Arm	Experimental	Children swalowed up to 3 intragastric balloons	Device: Swallowable Obalon® Gastric Balloon
Dietary and lifestyle changes Arm	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Swallowable Obalon® Gastric Balloon	Device		Obalon Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight loss (Kg)		3 months

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Weight > 97° pc -CDC BMI charts-

Exclusion Criteria:

Prevous abdominal surgery
Functional gastrointestinal motility disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bambino Gesù Children Hospital		Rome	Italy	00100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D063766	Pediatric Obesity
D009767	Obesity, Morbid

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided