Propel Drug-Eluting Sinus Stent Family Open Cohort
NCT05925985 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 215
Last updated 2026-01-20
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
- OTHER
-
NA-Observational Registry
NA Observational Registry
Sponsors & Collaborators
- lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-01
- Primary Completion
- 2025-02-19
- Completion
- 2025-09-01
- FDA Device
- Yes
Countries
- Germany
- United Kingdom
Study Locations
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