Propel Drug-Eluting Sinus Implant Family IBUKI Cohort
Recruiting now
Conditions studied: Chronic Rhinosinusitis (CRS)
In brief
To confirm clinical safety and performance for the PROPEL family of products when used according to IFUs and standard of care in Japan.
Key facts
- Study ID
- NCT07546682
- Run by
- Medtronic
- People needed
- 100
- Starts
- 2026-04-01
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-04-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
- Patient has, or is intended to receive or be treated with, an eligible Medtronic product
- Patient is consented within the enrollment window of the therapy received, as applicable
- Patient has a confirmed diagnosis of CRS, and is indicated for FESS per Japan standard practice
- FESS is successfully completed without the occurrence of major/significant complications that may confound study results
- Successful placement of 2 to 4 corticosteroid-eluting implants in the ethmoid or frontal sinus (1 implant per sinus) in accordance with implant IFUs
- NOVAPAK is the only hemostatic packing material placed bilaterally in ethmoid sinuses
You may not qualify if…
- Patient has clinical evidence of disease or a condition expected to compromise survival or ability to complete follow-up assessments through Month 6 (end of study)
- Participation is excluded by local law
- Patient is currently enrolled in, or plans to enroll in, any concurrent study that may confound the PSR results (i.e., no required intervention that could affect interpretation of all-around product safety and/or effectiveness)
- Patient has received biologic medication approved for the treatment of CRSwNP (e.g., dupilumab, mepolizumab) in ≤ 12 weeks prior to the baseline/procedure visit
- Patient is contraindicated in accordance with IFUs of PROPEL family implants and/or NOVAPAK
Where it is running
- Japanese Red Cross Asahikawa Hospital — Asahikawa, Japan (enrolling)
Full record on ClinicalTrials.gov
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