PROPEL Sinus Stent Safety and Effectiveness in ENT Patients
Data Collection
Collected from today forward - ProspectiveCohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: January 30, 2025
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives