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โ† Trials
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Propel Drug-Eluting Sinus Implant Family IBUKI Cohort

Recruitingn/aAges 18 Years - anyAllMedtronic
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค 12 weeks prior to the baseline/procedure visit * Patient is contraindicated in accordance with IFUs of PROPEL family implants and/or NOVAPAK
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What it tests

  • None, observational standard of care study
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Where

1 site
Japanese Red Cross Asahikawa Hospital
Asahikawa, Japan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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