Propel Drug-Eluting Sinus Implant Family IBUKI Cohort

NCT07546682 | Recruiting

• 1 other identifier: PSR ENT - IBUKI Cohort
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis (CRS)

Keywords

Chronic Rhinosinusitis, corticosteroid-eluting sinus implants, 22- item sinonasal outcome test

Outcome Measures

Primary Outcomes (1)

• SNOT-22 total score change

  SNOT-22 total score change from baseline to month 3

  baseline to month 3

Interventions

None, observational standard of care study OTHER

None, observational standard of care study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients implanted with corticosteroid-eluting implants following functional endoscopic sinus surgery in the Japanese CRS population

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic: lead

Study Sites (1)

Japanese Red Cross Asahikawa Hospital

Asahikawa, Japan

RECRUITING

Central Study Contacts

Katherine Schiller

CONTACT

763-526-8329; katherine.schiller@medtronic.com

Amita Patel

CONTACT

amita.patel@medtronic.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)