Product Surveillance Registry; Ear, Nose and Throat - EXTEND Cohort
NCT06671561 · Status: WITHDRAWN · Type: OBSERVATIONAL
Last updated 2025-05-15
Summary
The purpose of this study is to confirm long-term clinical safety and performance, acceptability of identified risks, and detect emerging risks based on factual evidence for the PROPEL family of products when used according to labeling in a real-world setting.
Conditions
- Chronic Rhinosinusitis (CRS)
Interventions
- DEVICE
-
Observational data collection from patients with chronic rhinosinusitis (CRS) receiving PROPEL sinus implant(s) following functional endoscopic sinus surgery (FESS)
Observational data collection
Sponsors & Collaborators
- lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-30
- Primary Completion
- 2026-08-31
- Completion
- 2027-04-30
- FDA Device
- Yes
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