Chronic Rhinosinusitis (CRS)NCT07546682
Propel Drug-Eluting Sinus Implant Family IBUKI Cohort
An observational study of Chronic Rhinosinusitis (CRS), run by Medtronic at 1 site in Japan.
Trial summary
To confirm clinical safety and performance for the PROPEL family of products when used according to IFUs and standard of care in Japan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (CRS)
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2026to Aug 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients implanted with corticosteroid-eluting implants following functional endoscopic sinus surgery in the Japanese CRS population
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amita Patel contact
Japan1 site, 1 recruiting
- Recruiting
Japanese Red Cross Asahikawa Hospital
Asahikawa
Kosuke Takabayashi, Dr., kosuketakabayashi@gmail.com
About this study
To confirm clinical safety and performance for the PROPEL family of products when used according to IFUs and standard of care in Japan.
Read the 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.
- Conditions
- Chronic Rhinosinusitis (CRS)
- Being tested
- None, observational standard of care study
- Keywords
- Chronic Rhinosinusitis, corticosteroid-eluting sinus implants, 22- item sinonasal outcome test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None, observational standard of care studyOther
None, observational standard of care study
What is being measured
The primary outcome is the main question the study is designed to answer.
SNOT-22 total score change
SNOT-22 total score change from baseline to month 3
Measured: baseline to month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (CRS)Studies of the same condition, open and under way.
- More trials run by MedtronicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546682
- Sponsor's protocol ID
- PSR ENT - IBUKI Cohort
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No