NCT05925985

Propel Drug-Eluting Sinus Stent Family Open Cohort

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 215 (actual)
• Sponsor: Medtronic · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
OTHER	NA-Observational Registry	NA Observational Registry

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-02-19
• Completion: 2025-09-01
• First posted: 2023-07-03
• Last updated: 2026-01-20

Locations

9 sites across 2 countries: Germany, United Kingdom

Regulatory

• FDA-regulated device study