Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05747014
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2023-02-07
Brief Title:
Novapak Prospective Observational Clinical Trial
Sponsor:
Medtronic Surgical Technologies
Organization:
Medtronic Surgical Technologies
Study Overview
Official Title:
Novapak Prospective Observational Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-03
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:
Novapak
Brief Summary:
The Novapak study is a prospective observational multi-site non-controlled non-randomized case-series with a 2 week and 1-month follow-up in adults undergoing nasalsinus surgery with Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively and is being conducted to obtain clinical data on the safety and effectiveness of the Novapak device under use as intended in the device indications
Detailed Description:
The primary objective is to assess the safety of the Novapak Nasal Sinus Packing and Stent device used as indicated post-operatively in patients undergoing nasalsinus surgery by
Collecting all AEs directly attributed to the device andor those that cannot be determined and calculating a point estimate and confidence interval
Collecting all AEs and calculating an overall rate and safety profile for the device
The secondary objectives are to confirm device effectiveness through assessing adhesions bleeding healing and health during the procedure 2 weeks and 1-month post treatment
Collecting all AEs directly attributed to the device andor those that cannot be determined and calculating a point estimate and confidence interval
Collecting all AEs and calculating an overall rate and safety profile for the device
The secondary objectives are to confirm device effectiveness through assessing adhesions bleeding healing and health during the procedure 2 weeks and 1-month post treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None