Chronic Rhinosinusitis (CRS)NCT06671561
Product Surveillance Registry; Ear, Nose and Throat - EXTEND Cohort
An observational study of Chronic Rhinosinusitis (CRS), run by Medtronic.
Trial summary
The purpose of this study is to confirm long-term clinical safety and performance, acceptability of identified risks, and detect emerging risks based on factual evidence for the PROPEL family of products when used according to labeling in a real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (CRS)
- What is being tested?
- Observational data collection from patients with chronic rhinosinusitis (CRS) receiving PROPEL sinus implant(s) following functional endoscopic sinus surgery (FESS)
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2025to Apr 2027
- How long will I take part?
- 12 Months
- 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: The study population is the European CRS population implanted with Propel implants. Patients included in the analysis population should have a confirmed diagnosis of CRS with or without nasal polyps (NP) and are indicated for FESS (defined as total SNOT-22 score >/= 20 and Lund-Mackay score >/= 1 in each sinus intended to receive an implant. Patients should not have received biologic medication approved for treatment of CRSwNP in </= 12 weeks prior to the baseline FESS procedure, and the FESS procedure should be completed with attempted placement of 1-4 corticosteroid-eluting implants in the ethmoid sinus and/or FSO. Patients should not have had packing materials or splints of any kind placed within the implants unless medically necessary.
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
About this study
Official title: Product Surveillance Registry (PSR) Ear, Nose and Throat- PROPEL Drug-Eluting Sinus Stent Family EXTEND Cohort
The purpose of this study is to confirm long-term clinical safety and performance, acceptability of identified risks, and detect emerging risks based on factual evidence for the PROPEL family of products when used according to labeling in a real-world setting.
Read the detailed description
Ongoing clinical investigation for the purpose(s) of:
- Providing continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products for their intended use
- Obtaining real-world performance and safety information from a global network of hospitals, clinics, and clinicians intended to represent the range of clinical environments in which Medtronic products are used
- Supporting post-market surveillance activities and post-approval studies that are initiated by Medtronic, regulated by local governments, or are conducted to fulfill government and/or regulatory authority requests
- Obtaining clinical evidence to guide the development and improvement of medical devices, therapies, device guidelines, and patient services/solutions
- Providing clinical data to support health economics and clinical outcomes research
Enrollment is estimated to take place at up to 10 sites in Europe over 12 months. A single site may enroll no more than 30 patients. Patients may be enrolled up to 60 days prior to the baseline procedure. Subjects will be followed for a total duration of12 months postoperatively.
- Conditions
- Chronic Rhinosinusitis (CRS)
- Being tested
- Observational data collection from patients with chronic rhinosinusitis (CRS) receiving PROPEL sinus implant(s) following functional endoscopic sinus surgery (FESS)
- Keywords
- PROPEL, Corticosteroid-eluting sinus implants, Product Surveillance Registry ENT, PROPEL Mini, PROPEL Contour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational data collection from patients with chronic rhinosinusitis (CRS) receiving PROPEL sinus implant(s) following functional endoscopic sinus surgery (FESS)Device
Observational data collection
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the SNOT-22 total score change from baseline to Month 6 in patients with CRS undergoing FESS
The primary objective is to characterize the 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. Baseline SNOT-22 total scores are expected to be higher prior to Functional Endoscopic Sinus Surgery (FESS) and implant of the sinus implant(s) . A decrease in SNOT-22 score at 6 months would indicate improvement in the patient's CRS symptoms.
Measured: From baseline (prior to FESS procedure and sinus implant) to 6 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start30 Jan 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionApr 2027 (estimated)
Why it stopped: New study design and data collection needed
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671561
- Sponsor's protocol ID
- EXTEND
- Status last verified
- May 2025
- First submitted
- 1 Nov 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Product Surveillance Registry (PSR) Ear, Nose and Throat- PROPEL Drug-Eluting Sinus Stent Family EXTEND Cohort
- ClinicalTrials.gov ID
- NCT06671561
- Acronym / sponsor ID
- EXTEND
- Conditions
- Chronic Rhinosinusitis (CRS)
- Keywords
- PROPEL, Corticosteroid-eluting sinus implants, Product Surveillance Registry ENT, PROPEL Mini, PROPEL Contour
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: New study design and data collection needed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MedtronicIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 4 Nov 2024 (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 long-term clinical safety and performance, acceptability of identified risks, and detect emerging risks based on factual evidence for the PROPEL family of products when used according to labeling in a real-world setting.
Detailed description
Ongoing clinical investigation for the purpose(s) of:
- Providing continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products for their intended use
- Obtaining real-world performance and safety information from a global network of hospitals, clinics, and clinicians intended to represent the range of clinical environments in which Medtronic products are used
- Supporting post-market surveillance activities and post-approval studies that are initiated by Medtronic, regulated by local governments, or are conducted to fulfill government and/or regulatory authority requests
- Obtaining clinical evidence to guide the development and improvement of medical devices, therapies, device guidelines, and patient services/solutions
- Providing clinical data to support health economics and clinical outcomes research
Enrollment is estimated to take place at up to 10 sites in Europe over 12 months. A single site may enroll no more than 30 patients. Patients may be enrolled up to 60 days prior to the baseline procedure. Subjects will be followed for a total duration of12 months postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is the European CRS population implanted with Propel implants. Patients included in the analysis population should have a confirmed diagnosis of CRS with or without nasal polyps (NP) and are indicated for FESS (defined as total SNOT-22 score >/= 20 and Lund-Mackay score >/= 1 in each sinus intended to receive an implant. Patients should not have received biologic medication approved for treatment of CRSwNP in </= 12 weeks prior to the baseline FESS procedure, and the FESS procedure should be completed with attempted placement of 1-4 corticosteroid-eluting implants in the ethmoid sinus and/or FSO. Patients should not have had packing materials or splints of any kind placed within the implants unless medically necessary.
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 |
|---|---|---|
| Observational data collection from patients with chronic rhinosinusitis (CRS) receiving PROPEL sinus implant(s) following functional endoscopic sinus surgery (FESS)Observational data collection | Device | – |
Primary outcome
To characterize the SNOT-22 total score change from baseline to Month 6 in patients with CRS undergoing FESS
Time frame: From baseline (prior to FESS procedure and sinus implant) to 6 months post procedure
The primary objective is to characterize the 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. Baseline SNOT-22 total scores are expected to be higher prior to Functional Endoscopic Sinus Surgery (FESS) and implant of the sinus implant(s) . A decrease in SNOT-22 score at 6 months would indicate improvement in the patient's CRS symptoms.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis (CRS), run by Medtronic.
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: withdrawn, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
To characterize the SNOT-22 total score change from baseline to Month 6 in patients with CRS undergoing FESS (time frame: From baseline (prior to FESS procedure and sinus implant) to 6 months post procedure). 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 15 May 2025.