Lap-Band Surgery on Adolescents for Safety and Efficacy (ALAGB)
This study is currently recruiting participants.
Verified September 2012 by New York University School of Medicine
Sponsor:
New York University School of Medicine
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: September 26, 2012
Last verified: September 2012
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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: | 100 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2015 (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
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, 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: | September 26, 2012 |
| 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 May 19, 2013