Ignite Creation Date:
2025-12-24 @ 3:58 PM
Ignite Modification Date:
2025-12-26 @ 7:58 AM
Study NCT ID:
NCT00775892
Status:
COMPLETED
Last Update Posted:
2011-08-09
First Post:
2008-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SeriACL™ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair
Sponsor:
Serica Technologies, Inc.
Organization:
Study Overview
Official Title:
A Multi-Center Open Label Study to Evaluate the SeriACL™ Device (Gen IB) for Primary Anterior Cruciate Ligament Repair
Status:
COMPLETED
Status Verified Date:
2011-08
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:
A multi-center single-arm clinical trial is being conducted to evaluate SeriACL device safety and performance during total anterior cruciate ligament (ACL) reconstruction.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: