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Sinus implant safety checked in japan

NCT ID NCT07546682

Knowledge-focused Sponsor: Medtronic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is checking how safe and effective the Propel sinus implant family is when used as part of standard care for chronic rhinosinusitis in Japan. About 100 people who have had sinus surgery will be followed for 3 months. The main goal is to see how their symptoms change using a standard questionnaire.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic rhinosinusitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic rhinosinusitis (CRS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Japanese Red Cross Asahikawa Hospital

    RECRUITING

    Asahikawa, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.