Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-31 @ 1:16 AM
Study NCT ID:
NCT01225250
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2010-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty
Sponsor:
DeNova Research
Organization:
Study Overview
Official Title:
An Open-Label, Randomized, 2-Arm Parallel Study Comparing the Efficacy, Ease of Use, and Safety of PDS Plated Cartilagenous Grafting Versus Non-Plated Cartilagenous Grafting as Performed Through Endonasal Rhinoplasty
Status:
COMPLETED
Status Verified Date:
2020-10
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 determine efficacy, safety, and ease of cartilaginous grafting using polydioxanone (PDS) plates in comparison to non-plated cartilaginous grafts as performed through an endonasal rhinoplasty approach in patients requiring a caudal septal extension (CSE) graft.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: