Propel Drug-Eluting Sinus Stent Family
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Interventions
- Other: NA-Observational Registry
- Registration Number
- NCT05925985
- Lead Sponsor
- Medtronic
- Brief 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). 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Propel Mini NA-Observational Registry Patients implanted with Propel Mini model implants Propel NA-Observational Registry Patients implanted with Propel model implants Propel Contour NA-Observational Registry Patients implanted with Propel Contour model implants
- Primary Outcome Measures
Name Time Method Long-term safety and efficacy of corticosteroid-eluting implants in patients with CRS undergoing Functional Endoscopic Sinus Surgery (FESS) 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.
- Secondary Outcome Measures
Name Time Method Endoscopic evaluation 12 months 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.
Trial Locations
- Locations (9)
Universitätsklinikum Freiburg Klinik für Hals, Nasen und Ohrenheilkunde
🇩🇪Freiburg, Germany
Katholisches Krankenhaus Hagen
🇩🇪Hagen, Germany
Städtisches Klinikum Karlsruhe GmbH
🇩🇪Karlsruhe, Germany
Saint Elisabeth Krankenhaus Köln-Hohenlind
🇩🇪Köln, Germany
Universitätsklinikum Schleswig-Holstein Campus Lübeck
🇩🇪Lübeck, Germany
HNO Praxis & Rhinologie Zentrum München
🇩🇪München, Germany
Universitätsklinikum Münster Klinik für Hals, Nasen und Ohrenheilkunde
🇩🇪Münster, Germany
Helios Dr Horst Schmidt Kliniken
🇩🇪Wiesbaden, Germany
Imperial College Healthcare NHS Trust - Charing Cross Hospital
🇬🇧London, United Kingdom