RecruitingNCT07546682

Propel Drug-Eluting Sinus Implant Family IBUKI Cohort

Sponsor

Medtronic

Enrollment

100 participants

Start Date

Apr 1, 2026

Study Type

OBSERVATIONAL

Conditions

To confirm clinical safety and performance for the PROPEL family of products when used according to IFUs and standard of care in Japan.

Min Age: 18 Years

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

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

Interested in this trial?

Get notified about updates and connect with the research team.