Propel Drug-Eluting Sinus Implant Family IBUKI Cohort

April 16, 2026 updated by: Medtronic
To confirm clinical safety and performance for the PROPEL family of products when used according to IFUs and standard of care in Japan.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PSR ENT - IBUKI Cohort

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Rhinosinusitis (CRS)

Clinical Trials on None, observational standard of care study

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe