NCT00587301

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 14 Years – 17 Years
• Healthy volunteers: Not accepted

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

Conditions

• Obesity
• DM

Interventions

Type	Name	Description
DEVICE	Lap-Band	Obesity and adolescents

Timeline

• Start date: 2005-06-01
• Primary completion: 2020-07-08
• Completion: 2020-07-08
• First posted: 2008-01-07
• Last updated: 2022-03-22
• Results posted: 2022-03-22

Locations

1 site across 1 country: United States