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
  Purpose

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


Condition Intervention Phase
Obesity
DM
Device: Lap-Band
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: June 2005
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lap-Band
Lap-band surgery in treatment of morbidly obese adolescents
Device: Lap-Band
Obesity and adolescents
Other Name: Lap-Band Adjustable Gastric Band (LAGB) Operation

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

  Eligibility

Ages Eligible for Study:   14 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587301

Contacts
Contact: Heekoung A Youn, M.A. 212 263 3166 heekoung.youn@med.nyu.edu

Locations
United States, New York
NYU SOM Recruiting
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Hope Foundation
Investigators
Principal Investigator: Christine Ren-Fielding, M.D. NYUSOM
  More Information

Additional Information:
No publications provided

Responsible Party: Heekoung A Youn, Research Coordinator, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00587301     History of Changes
Other Study ID Numbers: H# 11876, G050010
Study First Received: December 21, 2007
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:
Child Obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014