Propel Drug-Eluting Sinus Implant Family IBUKI Cohort
ConditionChronic Rhinosinusitis (CRS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedtronic
About this trial
To confirm clinical safety and performance for the PROPEL family of products when used according to IFUs and standard of care in Japan.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients implanted with corticosteroid-eluting implants following functional endoscopic sinus surgery in the Japanese CRS population
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
None, observational standard of care study
Other interventionNone, observational standard of care study
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
SNOT-22 total score change
SNOT-22 total score change from baseline to month 3
Time frame
baseline to month 3 Source ClinicalTrials.gov