Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT04858802
Status:
COMPLETED
Last Update Posted:
2023-04-21
First Post:
2021-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Clinical Evaluation of PROPEL® Contour Sinus Implant
Sponsor:
Intersect ENT
Organization:
Study Overview
Official Title:
The EXPAND Study: A Clinical Evaluation of PROPEL® Contour Sinus Implant Placement in the Frontal Sinus Ostium Following In-office Bilateral Balloon Dilation
Status:
COMPLETED
Status Verified Date:
2023-03
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:
EXPAND
Brief Summary:
The objective of this study is to evaluate the efficacy of PROPEL Contour placement following an in-office frontal sinus balloon dilation (SBD) in patients with chronic rhinosinusitis (CRS)
Detailed Description:
A post-market, randomized, intra-patient controlled, blinded multicenter study with 80 randomized subjects at up to 20 study centers.
After successful in-office bilateral balloon dilation of the frontal sinus ostium (FSO) using the VenSure™ Nav Balloon Device and Fiagon Cube Navigation System, patients will be randomized to receive one PROPEL Contour Sinus Implant on one side while the contralateral side serves as the control.
After successful in-office bilateral balloon dilation of the frontal sinus ostium (FSO) using the VenSure™ Nav Balloon Device and Fiagon Cube Navigation System, patients will be randomized to receive one PROPEL Contour Sinus Implant on one side while the contralateral side serves as the control.
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: