Propel Drug-Eluting Sinus Stent Family Open Cohort

NCT05925985 | Completed FDA Device

• 1 other identifier: PSR Ear, Nose and Throat
• Study Type: observational
• Target: 215
• Locations: 2 countries
• Sites: 9

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.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Endoscopic evaluation

  12 months

Study Arms (3)

Propel

Patients implanted with Propel model implants

Other: NA-Observational Registry

Propel Mini

Patients implanted with Propel Mini model implants

Other: NA-Observational Registry

Propel Contour

Patients implanted with Propel Contour model implants

Other: NA-Observational Registry

Interventions

NA-Observational Registry OTHER

NA Observational Registry

Propel; Propel Contour; Propel Mini

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

European CRS population implanted with Propel implants

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic: lead

Study Sites (9)

Saint Elisabeth Krankenhaus Köln-Hohenlind

Cologne, Germany

Location

Universitätsklinikum Freiburg Klinik für Hals, Nasen und Ohrenheilkunde

Freiburg im Breisgau, Germany

Location

Katholisches Krankenhaus Hagen

Hagen, Germany

Location

Städtisches Klinikum Karlsruhe GmbH

Karlsruhe, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, Germany

Location

HNO Praxis & Rhinologie Zentrum München

München, Germany

Location

Universitätsklinikum Münster Klinik für Hals, Nasen und Ohrenheilkunde

Münster, Germany

Location

Helios Dr Horst Schmidt Kliniken

Wiesbaden, Germany

Location

Imperial College Healthcare NHS Trust - Charing Cross Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: July 3, 2023
• Study Start: June 1, 2023
• Primary Completion: February 19, 2025
• Study Completion: September 1, 2025
• Last Updated: January 20, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8); GB (1)