Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501085
Status:
COMPLETED
Last Update Posted:
2015-01-19
First Post:
2007-07-11
Brief Title:
LAP-BAND AP Early Experience Trial APEX
Sponsor:
Apollo Endosurgery Inc
Organization:
Apollo Endosurgery Inc
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2015-01
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 evaluate the LAP-BAND AP System in severely obese patients
Detailed Description:
The primary objective of this study was to collect additional information about the safety and effectiveness of the LAP-BAND AP System in a real-life clinical setting Effectiveness was assessed through the collection of weight loss data as well as other secondary effectiveness measurements Safety was assessed by the incidence and severity of adverse events AEs related to treatment
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