Chronic Rhinosinusitis (Diagnosis)NCT05925985
Propel Drug-Eluting Sinus Stent Family Open Cohort
An observational study of Chronic Rhinosinusitis (Diagnosis), run by Medtronic at 9 sites in 2 countries.
Trial summary
The purpose of this study is to confirm the long-term clinical safety and performance, acceptability of identified risks, and to detect emerging risks based on factual evidence for the PROPEL family of products when used according to labeling (in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- NA-Observational Registry
- How many people
- 215 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 1 Jun 2023to 1 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: European CRS population implanted with Propel implants
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
Who cannot join
- Patient who is, or is expected to be, inaccessible for follow-up
- Participation is excluded by local law
- Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany8 sites
Saint Elisabeth Krankenhaus Köln-Hohenlind
Cologne
Universitätsklinikum Freiburg Klinik für Hals, Nasen und Ohrenheilkunde
Freiburg im Breisgau
Katholisches Krankenhaus Hagen
Hagen
Städtisches Klinikum Karlsruhe GmbH
Karlsruhe
Universitätsklinikum Schleswig-Holstein Campus Lübeck
Lübeck
HNO Praxis & Rhinologie Zentrum München
München
Universitätsklinikum Münster Klinik für Hals, Nasen und Ohrenheilkunde
Münster
Helios Dr Horst Schmidt Kliniken
Wiesbaden
United Kingdom1 site
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London
About this study
The purpose of this study is to confirm the long-term clinical safety and performance, acceptability of identified risks, and to detect emerging risks based on factual evidence for the PROPEL family of products when used according to labeling (in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery). Additionally, this study intends to collect data on use of corticosteroid-eluting implants in the European CRS population. Data collected will be used to ensure continued consistency between clinical data, the information materials supplied by the manufacturer, and the risk management documentation.
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- NA-Observational Registry
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NA-Observational RegistryOther
NA Observational Registry
| Study group | Role | What they receive |
|---|---|---|
| Propel | Patients implanted with Propel model implants Receives: Other: NA-Observational Registry | |
| Propel Mini | Patients implanted with Propel Mini model implants Receives: Other: NA-Observational Registry | |
| Propel Contour | Patients implanted with Propel Contour model implants Receives: Other: NA-Observational Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term safety and efficacy of corticosteroid-eluting implants in patients with CRS undergoing Functional Endoscopic Sinus Surgery (FESS)
The primary efficacy endpoint is Sino-Nasal Outcome Test 22 item (SNOT-22) total score change from baseline to Month 6. The SNOT-22 assesses 22 symptoms associated with Chronic Rhinosinusitis (CRS) with a value from 0 (no problem) to 5 (problem as bad as it can be). The total score is assessed by summing the score for each of the 22 items. Total SNOT-22 scores of 20 and greater in patients with CRS meet criteria defined by European Position Paper on Rhinosinusitis and Nasal Polyps 2020 (EPOS 2020) as indicated for Functional Endoscopic Sinus Surgery (FESS). Baseline SNOT-22 total scores are expected to be higher at baseline prior to FESS. A decrease in SNOT-22 score at 6 months would indicate improvement in the patient's CRS symptoms.
Measured: 6 months
Secondary outcomes (1)
Endoscopic evaluation
Endoscopic evaluation scoring from baseline to month 3, 6, and12. Endoscopic evaluation is the physician's assessment via endoscopy of the adhesion/scarring, polyps, patency, polypoid oedema, and middle turbinate lateralization of the sinuses from 0 (none) to 3-4 (most severe) prior to FESS, and following FESS and Propel stent placement at 3, 6 and 12 months. Lower scores at follow-up would indicate improvement in the patient's CRS and healing compared to baseline.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jun 2023
- Primary completion19 Feb 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (Diagnosis)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925985
- Sponsor's protocol ID
- PSR Ear, Nose and Throat
- Status last verified
- Oct 2025
- First submitted
- 19 May 2023
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propel Drug-Eluting Sinus Stent Family Open Cohort
- ClinicalTrials.gov ID
- NCT05925985
- Acronym / sponsor ID
- PSR Ear, Nose and Throat
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to confirm the long-term clinical safety and performance, acceptability of identified risks, and to detect emerging risks based on factual evidence for the PROPEL family of products when used according to labeling (in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery). Additionally, this study intends to collect data on use of corticosteroid-eluting implants in the European CRS population. Data collected will be used to ensure continued consistency between clinical data, the information materials supplied by the manufacturer, and the risk management documentation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Propel | – | Other: NA-Observational RegistryPatients implanted with Propel model implants |
| Propel Mini | – | Other: NA-Observational RegistryPatients implanted with Propel Mini model implants |
| Propel Contour | – | Other: NA-Observational RegistryPatients implanted with Propel Contour model implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- European CRS population implanted with Propel implants
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patient who is, or is expected to be, inaccessible for follow-up
- Participation is excluded by local law
- Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NA-Observational RegistryNA Observational Registry | Other | Propel, Propel Contour, Propel Mini |
Primary outcome
Long-term safety and efficacy of corticosteroid-eluting implants in patients with CRS undergoing Functional Endoscopic Sinus Surgery (FESS)
Time frame: 6 months
The primary efficacy endpoint is Sino-Nasal Outcome Test 22 item (SNOT-22) total score change from baseline to Month 6. The SNOT-22 assesses 22 symptoms associated with Chronic Rhinosinusitis (CRS) with a value from 0 (no problem) to 5 (problem as bad as it can be). The total score is assessed by summing the score for each of the 22 items. Total SNOT-22 scores of 20 and greater in patients with CRS meet criteria defined by European Position Paper on Rhinosinusitis and Nasal Polyps 2020 (EPOS 2020) as indicated for Functional Endoscopic Sinus Surgery (FESS). Baseline SNOT-22 total scores are expected to be higher at baseline prior to FESS. A decrease in SNOT-22 score at 6 months would indicate improvement in the patient's CRS symptoms.
1 secondary outcome
Endoscopic evaluation
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis (Diagnosis), run by Medtronic at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term safety and efficacy of corticosteroid-eluting implants in patients with CRS undergoing Functional Endoscopic Sinus Surgery (FESS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.