NCT00592202

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2007

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

April 2, 2014

Status Verified

March 1, 2014

Enrollment Period

8.2 years

First QC Date

December 27, 2007

Last Update Submit

March 31, 2014

Conditions

Morbid Obesity

Keywords

Morbid obesityAdolescentsGastric restrictive procedureAdjustable gastric bandTreatment

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    Every six months

Secondary Outcomes (2)

  • Resolution of comorbidities

    every six months

  • Assess the status of comorbidities and changes in quality of life scores from baseline.

    every six months

Study Arms (1)

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

Placement of an adjustable gastric bandDEVICE

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.

1

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UIMC

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert Kanard, M.D.

    Division of Pediatric Surgery, UIC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Visiting Assistant Professor/MD

Study Record Dates

First Submitted

December 27, 2007

First Posted

January 11, 2008

Study Start

December 1, 2004

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

April 2, 2014

Record last verified: 2014-03

Locations

US(1)