Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-27 @ 9:14 PM
Study NCT ID:
NCT01623050
Status:
COMPLETED
Last Update Posted:
2014-11-05
First Post:
2012-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium
Sponsor:
SinuSys Corporation
Organization:
Study Overview
Official Title:
SinuSys Patency of Maxillary Sinus Ostia Study
Status:
COMPLETED
Status Verified Date:
2014-10
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 assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.
Detailed Description:
A multicenter, single-arm, prospective study conducted to assess the safety and effectiveness of a new osmotically-driven, low-pressure expansion device for dilation of maxillary sinus ostia in patients with (CRS) Chronic Rhinosinusitis
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?: