Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00447590
Status:
COMPLETED
Last Update Posted:
2014-10-02
First Post:
2007-03-14
Brief Title:
Effectiveness and Safety Study of LAP-BAND Treatment for Obese Adolescents
Sponsor:
Apollo Endosurgery Inc
Organization:
Apollo Endosurgery Inc
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether the LAP-BAND system is safe and effective in morbidly obese adolescents
Detailed Description:
The primary objective of this study was to evaluate the safety and effectiveness of the LAP-BAND System in a morbidly obese adolescent population ages 14 to 17 years The secondary objectives were to assess associated changes from baseline in obesity-related comorbidities as well as psychosocial functioning
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None