Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-28 @ 12:18 AM
Study NCT ID:
NCT02756351
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2016-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Efficacy and Safety Study of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization
Sponsor:
CytaCoat AB
Organization:
Study Overview
Official Title:
A Double-blinded Randomized Clinical Pilot Trial of Nasal Prongs With Proprietary Surface Coating Aiming to Reduce Bacterial Colonization
Status:
COMPLETED
Status Verified Date:
2016-12
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 study is a first step in establishing the safety and efficacy of the CytaCoat technology when applied to a medical device such as a nasal prong and the clinical data generated will serve as a basis for continuous studies in clinically significant settings such as the neonatal care units.
Detailed Description:
None
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?: