Chronic Rhinosinusitis
Conditions
Interventions
None listed
Sponsors
Nozawa Mika
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 - 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
Exclusion criteria
Exclusion criteria: - 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 visit - Patient is contraindicated in accordance with IFUs of PROPEL and/or NOVAPAK
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to assess the clinical outcomes of corticosteroid-eluting implants in patients with CRS undergoing FESS. The primary endpoint is SNOT-22 total score change from baseline to Month 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of the study is to collect data on the use of corticosteroid-eluting implants in the Japanese CRS population. The following secondary endpoints will be assessed at baseline and follow-up visits: - PRO and HRQL measures - SNOT-22 (Month 3, 6) - NSQ (Months 3, 6) - EQ-5D-5L (Months 3, 6) - Endoscopic evaluation (Months 1, 3, 6) - Ethmoid sinus (both sinuses) - Adhesion/scarring - Middle turbinate lateralization - Nasal Polyps - Frontal recess/FSO (implanted sinuses only) - Adhesion/scarring - Patency - Polypoid oedema - Need for postoperative intervention (oral steroids and revision surgery) in all ethmoid sinuses and implanted frontal sinuses (Months 1, 3, 6) | — |
Contacts
Public ContactMika Nozawa
Medtronic Japan Co., Ltd.
Outcome results
None listed