Laparoscopic Adjustable Gastric Banding as a Treatment fo... | NCT00592202

Studies
Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents

NCT00592202

Sponsor

University of Illinois at Chicago

Status

Completed

Last Update Posted

Apr 2, 2014Estimated

Enrollment

37Actual

Phase

Not Applicable

Conditions

Morbid Obesity

Interventions

Placement of an adjustable gastric band

Countries

United States

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

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

Dec 2004

Primary Completion Date

Feb 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

Dec 27, 2007

First Submission Date that Met QC Criteria

Dec 27, 2007

First Posted Date

Jan 11, 2008Estimated

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

Mar 31, 2014

Last Update Posted Date

Apr 2, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bob Kanard, Visiting Assistant Professor/MD, University of Illinois at ChicagoPrincipal Investigator

Lead Sponsor

University of Illinois at ChicagoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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 purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents.

Detailed Description

The aim of this research is to evaluate the safety and efficacy of the use of the Lap-Band system in the morbidly obese adolescent population in the United States. We also propose to take advantage of the opportunity for liver biopsy and the data collected for the FDA study in adolescents to answer several questions: 1) what is the true incidence of non-alcoholic fatty liver disease (NAFLD) and its variants in morbidly obese adolescents; 2) what is the course of the NAFLD disease in adolescents who have undergone weight loss, including the progression from steatosis to NASH/ fibrosis or the progression of NASH to cirrhosis? 3) What are the factors implicated in this progression and 4) Is there a link between the excess visceral fat, MS and NAFLD as assessed by parallel changes in metabolic syndrome (MS) and NAFLD following weight loss intervention. The LAPBAND may provide obese adolescents with a significantly less morbid and reversible surgical option for weight loss.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Adolescents between the ages 14 through 17 with a BMI of 40 or more or with a BMI of 35 or more and with an obesity related comorbidity will undergo placement of an adjustable gastric band	Device: Placement of an adjustable gastric band

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placement of an adjustable gastric band	Device	Laparoscopic placement of an adjustable gastric band around the upper portion of the stomach and subsequent adjustments of the band via a subcutaneous port as needed to maintain appropriate restriction.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight loss		Every six months

Secondary Outcomes

Measure	Description	Time Frame
Resolution of comorbidities		every six months
Assess the status of comorbidities and changes in quality of life scores from baseline.		every six months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages 14 through 17
BMI greater than 40
BMI 35 to 40 and also having an obesity related comorbidity
Have a history of working in a multidisciplinary weight loss program utilizing nutritional training, behavior modification, and activity training

Exclusion Criteria:

Subject history of congenital or acquired anomalies fo the gastrointestinal tract
Severe cardiopulmonary or other serious organic disease
Severe coagulopathy
Hepatic insufficiency or cirrhosis
History of bariatric gastric or esophageal surgery
History of intestinal obstruction or adhesive peritonitis
History of esophageal motility disorders
Type I diabetes

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 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

Name	Affiliation	Role
Robert Kanard, M.D.	Division of Pediatric Surgery, UIC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UIMC		Chicago	Illinois	60612	United States

Type	Date	Date Unknown
Release	May 19, 2014
Reset	Jun 19, 2014
Release	Feb 2, 2022
Reset	Feb 25, 2022

Submission Tracking

Estimated Results First Submitted Date

May 19, 2014

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 19, 2014			Jun 19, 2014
Feb 2, 2022

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided