Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT03473405
Status:
UNKNOWN
Last Update Posted:
2018-12-13
First Post:
2018-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Air Barrier System for the Reduction of Airborne Colony Forming Units During Total Knee Arthroplasty
Sponsor:
Nimbic Systems, LLC
Organization:
Study Overview
Official Title:
Air Barrier System for the Reduction of Airborne Particulate and Colony Forming Units (CFU) During Total Knee Arthroplasty
Status:
UNKNOWN
Status Verified Date:
2018-12
Last Known Status:
NOT_YET_RECRUITING
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:
This objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g., bacteria) present at a surgery site during total knee arthroplasty surgeries.
Detailed Description:
The Air Barrier System (ABS) is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the ABS can reduce the presence of airborne CFU at the surgery site during total knee arthroplasty surgery.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: