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Lap-Band Surgery on Adolesecents (ALAGB)
This study has been completed.
First Received: December 21, 2007   No Changes Posted
Sponsors and Collaborators: New York University School of Medicine
Hope Foundation
Information provided by: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00587301
  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
Adolescents
DM
Device: Lap-Band
Phase II
Phase III

MedlinePlus related topics: Obesity Obesity in Children Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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)

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 ]

Enrollment: 50
Study Start Date: June 2005
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Lap-Band: Active Comparator
Lap-band surgery in treatment of morbidly obese adolescents
Device: Lap-Band
Obesity and adolescents

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

Sponsors and Collaborators
New York University School of Medicine
Hope Foundation
Investigators
Principal Investigator: Christine Ren, M.D. NYUSOM
  More Information

Additional Information:
No publications provided

Responsible Party: NYUSOM ( Christine Ren, M.D. )
Study ID Numbers: H# 11876, G050010
Study First Received: December 21, 2007
Last Updated: December 21, 2007
ClinicalTrials.gov Identifier: NCT00587301     History of Changes
Health Authority: United States: Food and Drug Administration;   NYUSOM IBRA

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

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders
Overweight
Overnutrition

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

ClinicalTrials.gov processed this record on May 07, 2009