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Product Surveillance Registry (PSR) Ear, Nose and Throat- PROPEL Drug-Eluting Sinus Stent Family EXTEND Cohort
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.
Ongoing clinical investigation for the purpose(s) of: * Providing continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products for their intended use * Obtaining real-world performance and safety information from a global network of hospitals, clinics, and clinicians intended to represent the range of clinical environments in which Medtronic products are used * Supporting post-market surveillance activities and post-approval studies that are initiated by Medtronic, regulated by local governments, or are conducted to fulfill government and/or regulatory authority requests * Obtaining clinical evidence to guide the development and improvement of medical devices, therapies, device guidelines, and patient services/solutions * Providing clinical data to support health economics and clinical outcomes research Enrollment is estimated to take place at up to 10 sites in Europe over 12 months. A single site may enroll no more than 30 patients. Patients may be enrolled up to 60 days prior to the baseline procedure. Subjects will be followed for a total duration of12 months postoperatively.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
January 30, 2025
Primary Completion Date
August 1, 2026
Completion Date
April 1, 2027
Last Updated
May 15, 2025
Observational data collection from patients with chronic rhinosinusitis (CRS) receiving PROPEL sinus implant(s) following functional endoscopic sinus surgery (FESS)
DEVICE
Lead Sponsor
Medtronic
NCT07383402
NCT07119879
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05248997