Chronic Rhinosinusitis (CRS)
Conditions
Keywords
Chronic Rhinosinusitis, corticosteroid-eluting sinus implants, 22- item sinonasal outcome test
Brief summary
To confirm clinical safety and performance for the PROPEL family of products when used according to IFUs and standard of care in Japan.
Detailed description
This study intends to collect data on the use of the PROPEL family of corticosteroid-eluting implants in the Japanese chronic rhinosinusitis (CRS) population to confirm clinical safety and performance for the PROPEL family of products when used according to IFUs and standard of care in Japan.
Interventions
OTHERNone, observational standard of care study
None, observational standard of care study
Sponsors
Medtronic
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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
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/procedure visit * Patient is contraindicated in accordance with IFUs of PROPEL family implants and/or NOVAPAK
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SNOT-22 total score change | baseline to month 3 | SNOT-22 total score change from baseline to month 3 |
Countries
Japan
Contacts
CONTACTKatherine Schiller
CONTACTAmita Patel
Outcome results
None listed