Lap-Band Surgery on Adolesecents - Tabular View

Tracking Information

First Received Date ^ICMJE

December 21, 2007

Last Updated Date

December 21, 2007

Start Date ^ICMJE

June 2005

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To demonstrate the safety and efficacy of the use of the LAP-BAND® System in the morbidly obese adolescent population. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

The secondary objective is to assess the status of co-morbidities and changes in quality of life from baseline. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Lap-Band Surgery on Adolesecents

Official Title ^ICMJE

A Prospective, Open-Label Study to Evaluate the Safety and Efficacy of Lap-Band® Adjustable Gastric Band (LAGB®) Operations in the Treatment of Morbidly Obese Adolescents (Ages 14-17)

Brief Summary

This study is to demonstrate the safety and efficacy of the use of the LAP-BAND surgery in the morbidly obese adolescent population.

Detailed Description

STUDY OBJECTIVES: Is to demonstrate the safety and efficacy of the use of the LAP-BAND® System in the morbidly obese adolescent population in the United States, and therefore provide these individuals with a significantly less morbid and reversible surgical option for weight loss.

STUDY VARIABLES:The primary efficacy variable is weight loss evaluated in terms of % excess weight loss (EWL).

DESIGN:Prospective, open-label, and single center

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Obesity
Adolescents
DM

Intervention ^ICMJE

Device: Lap-Band

Study Arms / Comparison Groups

Active Comparator: Lap-band surgery in treatment of morbidly obese adolescents

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Be at least 14 and less than 18 years of age at the time of enrollment into the study.
Have a BMI of at least 40
Have a history of obesity for at least 5 years, including failed attempts at diet and medical management of obesity.
Confirmation by a psychologist or psychiatrist experienced with adolescents that the subject is sufficiently mature emotionally to comply with the study protocol.

Express willingness to follow protocol requirements.

•Assure investigators that subject, if female of childbearing potential, is using an appropriate form of contraception.

Exclusion Criteria:

Intention or need to have another surgical procedure for weight reduction within 12 months of Lap Band placement.
History of congenital or acquired anomalies of the G.I. tract, such as; congenital or acquired intestinal telangiectasia, Crohn's disease or ulcerative colitis; severe cardiopulmonary disease or severe coagulapathy; hepatic insufficiency or cirrhosis.
Presence of dysphagia or documented esophageal dysmotility.
Patients with autoimmune connective tissue disorders
Patients with acute abdominal infections
Pregnancy or intention of becoming pregnant in the next 12 months.
Presence of psychiatric problems or immaturity which would compromise cooperation with the study protocol.
History of previous bariatric surgery, intestinal obstruction or adhesive peritonitis.
Presence of localized or systemic infection at the time of surgery.
Chronic use of aspirin and/or non-steroidal anti-inflammatory medications and unwillingness to discontinue the use of these concomitant medications.
History of gastric or esophageal surgery.
Use of weigh loss medications simultaneously

Gender

Both

Ages

14 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00587301

Responsible Party

Christine Ren, M.D., NYUSOM

Study ID Numbers ^ICMJE

H# 11876, G050010

Study Sponsor ^ICMJE

New York University School of Medicine

Collaborators ^ICMJE

Hope Foundation

Investigators ^ICMJE

Principal Investigator:

Christine Ren, M.D.

NYUSOM

Information Provided By

New York University School of Medicine

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP