Actively Recruiting
Propel Drug-Eluting Sinus Implant Family IBUKI Cohort
Led by Medtronic · Updated on 2026-04-23
100
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To confirm clinical safety and performance for the PROPEL family of products when used according to IFUs and standard of care in Japan.
CONDITIONS
Official Title
Propel Drug-Eluting Sinus Implant Family IBUKI Cohort
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or legally authorized representative provides consent per local requirements
- Patient has or will receive an eligible Medtronic product
- Patient is consented within the enrollment window for the therapy received
- Confirmed diagnosis of chronic rhinosinusitis (CRS) and indication for FESS per Japan standard practice
- Successful completion of FESS without major complications
- Placement of 2 to 4 corticosteroid-eluting implants in ethmoid or frontal sinuses as per instructions
- NOVAPAK is the only hemostatic packing material used bilaterally in ethmoid sinuses
You will not qualify if you...
- Patient has disease or condition expected to reduce survival or ability to complete follow-up through 6 months
- Participation prohibited by local law
- Currently enrolled or planning to enroll in any concurrent study that may affect results
- Received biologic medication for CRSwNP (e.g., dupilumab, mepolizumab) within 12 weeks before baseline or procedure
- Contraindicated according to PROPEL implant or NOVAPAK instructions for use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Japanese Red Cross Asahikawa Hospital
Asahikawa, Japan
Actively Recruiting
Research Team
K
Katherine Schiller
CONTACT
A
Amita Patel
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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