Propel Drug-Eluting Sinus Implant Family IBUKI Cohort | NCT07546682

Studies
Propel Drug-Eluting Sinus Implant Family IBUKI Cohort

NCT07546682

Sponsor

Medtronic

Status

Recruiting

Last Update Posted

Apr 23, 2026Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Chronic Rhinosinusitis (CRS)

Interventions

None, observational standard of care study

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2026Estimated

Primary Completion Date

May 2027Estimated

Completion Date

Aug 2027Estimated

First Submitted Date

Apr 16, 2026

First Submission Date that Met QC Criteria

Apr 16, 2026

First Posted Date

Apr 23, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2026

Last Update Posted Date

Apr 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Name	Type	Description	Arm Group Labels	Other Names
None, observational standard of care study	Other	None, observational standard of care study

Measure	Description	Time Frame
SNOT-22 total score change	SNOT-22 total score change from baseline to month 3	baseline to month 3

Eligibility Module

Eligibility 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 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Katherine Schiller	Contact	763-526-8329		katherine.schiller@medtronic.com
Amita Patel	Contact			amita.patel@medtronic.com