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

This study is currently recruiting participants.

Verified by University of Illinois, April 2009

First Received: December 27, 2007 Last Updated: April 22, 2009 History of Changes

Sponsored by:	University of Illinois
Information provided by:	University of Illinois
ClinicalTrials.gov Identifier:	NCT00592202

Purpose

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

Condition	Intervention
Morbid Obesity	Procedure: Placement of an adjustable gastric band

MedlinePlus related topics: Obesity Obesity in Children

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents

Further study details as provided by University of Illinois:

Primary Outcome Measures:

Secondary Outcome Measures:

Resolution of comorbidities [ Time Frame: every six months ] [ Designated as safety issue: No ]
Complications [ Time Frame: every six months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	December 2004
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	Procedure: Placement of an adjustable gastric band 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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592202

Contacts

Contact: Mark J Holterman, M.D.	312-413-7707	rmasjet@uic.edu
Contact: Mark J Holterman, M.D.	312-413-7707

Locations

United States, Illinois
UIMC	Recruiting
Chicago, Illinois, United States, 60612
Contact: Mark J Holterman, M.D. 312-413-7707 rmasjet@uic.edu
Principal Investigator: Mark J Holterman, M.D.

Sponsors and Collaborators

University of Illinois

Investigators

Principal Investigator:

Mark J Holterman, M.D.

Division of Pediatric Surgery, UIC

More Information

No publications provided

Responsible Party:	Division of Pediatric Surgery, UIC ( Allen F. Browne, M.D. )
Study ID Numbers:	2004-0732
Study First Received:	December 27, 2007
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00592202 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Illinois:

Morbid obesity
Adolescents
Gastric restrictive procedure
Adjustable gastric band
Treatment

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Benzocaine

Nutrition Disorders
Overweight
Overnutrition
Obesity, Morbid

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Overweight
Overnutrition
Obesity, Morbid

ClinicalTrials.gov processed this record on May 07, 2009