Propel Drug-Eluting Sinus Stent Family

Chronic Rhinosinusitis (Diagnosis) Clinical Trial

Official title:

Propel Drug-Eluting Sinus Stent Family Open Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05925985
• Other study ID #: PSR Ear, Nose and Throat
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: September 2025

Study information

• Verified date: February 2024
• Source: Medtronic
• Contact: Katherine Schiller
• Phone: 763-526-8329
• Email: katherine.schiller[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Rhinosinusitis (Diagnosis)
• Sinusitis

Intervention

Other:
• NA-Observational Registry
NA Observational Registry

Locations

Country	Name	City	State
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
United Kingdom	Imperial College Healthcare NHS Trust - Charing Cross Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 months