Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2026-03-02 @ 10:34 PM
Study NCT ID:
NCT01262105
Status:
COMPLETED
Last Update Posted:
2012-04-11
First Post:
2010-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Device to Reduce Surgery Site Contamination - Spine
Sponsor:
Nimbic Systems, LLC
Organization:
Study Overview
Official Title:
Reduction of Airborne Microbes in the Surgical Field During Spine Procedures Using Directed Local Airflow
Status:
COMPLETED
Status Verified Date:
2012-04
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 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 spinal procedures.
Detailed Description:
The Air Barrier System 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 Air Barrier System can reduce the presence of airborne colony-forming units at the surgery site during spinal procedures.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: