Lap-Band Surgery on Adolescents for Safety and Efficacy (ALAGB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by New York University School of Medicine
Sponsor:
Collaborator:
Hope Foundation
Information provided by (Responsible Party):
Heekoung A Youn, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00587301
First received: December 21, 2007
Last updated: May 19, 2014
Last verified: May 2014

December 21, 2007
May 19, 2014
June 2005
December 2018   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00587301 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Lap-Band Surgery on Adolescents for Safety and Efficacy
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)

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

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

Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • DM
Device: Lap-Band
Obesity and adolescents
Other Name: Lap-Band Adjustable Gastric Band (LAGB) Operation
Active Comparator: Lap-Band
Lap-band surgery in treatment of morbidly obese adolescents
Intervention: Device: Lap-Band
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2019
December 2018   (final data collection date for primary outcome measure)

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 coagulopathy; 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
Both
14 Years to 17 Years
No
Contact: Heekoung A Youn, M.A. 212 263 3166 heekoung.youn@med.nyu.edu
United States
 
NCT00587301
H# 11876, G050010
Yes
Heekoung A Youn, New York University School of Medicine
New York University School of Medicine
Hope Foundation
Principal Investigator: Christine Ren-Fielding, M.D. NYUSOM
New York University School of Medicine
May 2014

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