Actively Recruiting
Propel Drug-Eluting Sinus Implant Family IBUKI Cohort
Led by Medtronic · Updated on 2026-04-23
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting data on the PROPEL family of corticosteroid-eluting sinus implants used in Japanese patients with chronic rhinosinusitis (CRS). The study aims to confirm the clinical safety and performance of these implants when used according to instructions for use (IFUs) and standard care practices in Japan. This observational study focuses on patients undergoing treatment including functional endoscopic sinus surgery (FESS). Participants receive standard care treatment for CRS, including FESS, followed by the placement of 2 to 4 PROPEL corticosteroid-eluting implants in the ethmoid or frontal sinuses according to device guidelines. The study observes the use of these implants in routine clinical practice without introducing additional experimental treatments or interventions. During the study, researchers will track changes in the Sino-Nasal Outcome Test-22 (SNOT-22) total score from baseline to three months after treatment to assess symptom improvements. Participants are monitored for safety and effectiveness outcomes through six months, with follow-up visits to collect clinical data. The study duration and procedures align with standard care protocols and implant use instructions.
CONDITIONS
Brief 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 authorization and/or consent per institutional and geographic requirements
- Patient has, or is intended to be treated with, an eligible Medtronic product
- Patient is consented within the enrollment window of the therapy received
- Patient has a confirmed diagnosis of chronic rhinosinusitis and indication for functional endoscopic sinus surgery (FESS) per Japan standard practice
- FESS is successfully completed without major complications that could affect study results
- Successful placement of 2 to 4 corticosteroid-eluting implants in the ethmoid or frontal sinuses according to implant instructions for use
- NOVAPAK is the only hemostatic packing material placed bilaterally in ethmoid sinuses
You will not qualify if you...
- Patient has a disease or condition expected to compromise survival or ability to complete follow-up through month 6
- Participation is excluded by local law
- Patient is currently enrolled in or plans to enroll in another study that may affect interpretation of product safety or effectiveness
- Patient has received biologic medication approved for treatment of chronic rhinosinusitis with nasal polyps within 12 weeks before baseline or procedure visit
- Patient is contraindicated according to instructions for use of PROPEL implants and/or NOVAPAK
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 months
Participants who undergo routine care with the PROPEL corticosteroid-eluting implants are observed to confirm clinical safety and performance.
Visits as per standard of care during follow-up
Trial Site Locations
Total: 1 location
1
Japanese Red Cross Asahikawa Hospital
Asahikawa, Japan
Actively Recruiting
Research Team
K
Katherine Schiller
A
Amita Patel
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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