Lap-Band Surgery on Adolescents for Safety and Efficacy

Not Applicable

Completed

• Conditions: DM; Obesity
• Interventions: Device: Lap-Band

• Registration Number: NCT00587301
• Lead Sponsor: NYU Langone Health

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 Timeline

• Study Start: 2005-06
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-07
• Primary Completion: 2020-07-08
• Study Completion: 2020-07-08
• Results First Submitted: 2022-01-04
• Status Verified: 2022-03
• Results First Submitted QC: 2022-03-21
• Last Update Submitted: 2022-03-21
• Results First Posted: 2022-03-22
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lap-Band	Lap-Band	Lap-band surgery in treatment of morbidly obese adolescents

Primary Outcome Measures

Name	Time	Method
Percentage of Excess Weight Loss (EWL)	Year 5

Secondary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	Year 5

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States