Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231062
Status:
COMPLETED
Last Update Posted:
2011-07-08
First Post:
2005-09-30
Brief Title:
Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses CLEAR
Sponsor:
Acclarent
Organization:
Acclarent
Study Overview
Official Title:
Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses CLEAR
Status:
COMPLETED
Status Verified Date:
2024-07
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:
A multi-center non-randomized prospective post-market evaluation of sinuplasty in paranasal sinuses
Detailed Description:
Sinusitis is a common healthcare problem that significantly reduces quality of life for people around the world Patients suffer from headache facial discomfort nasal congestion nasal drainage loss of the sense of smell and malaise Sinusitis is responsible for major healthcare expenditure and loss of workplace productivity
The rationale of this study is to collect data on the effectiveness and safety of balloon dilation of the Frontal Maxillary and Sphenoid sinuses by treating patients and observing them for a six month period of time following the procedure Six month follow-up data is important to demonstrate the effectiveness of balloon catheter dilation
The rationale of this study is to collect data on the effectiveness and safety of balloon dilation of the Frontal Maxillary and Sphenoid sinuses by treating patients and observing them for a six month period of time following the procedure Six month follow-up data is important to demonstrate the effectiveness of balloon catheter dilation
Study Oversight
Has Oversight DMC:
None
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?:
None