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Pressure-enabled Retrograde Occlusive Therapy With Embolization for Control of Thyroid Disease (PROTECT Registry): A Multicenter Registry
Sponsor: Sarasota Memorial Health Care System
Summary
Multi-center registry study to evaluate disease-related quality of life outcomes of thyroid embolization via pressure-enabled delivery (PED-TAE). Additional technical success data on parenchymal volume reduction, thyroid function tests changes and post-procedural complications will be recorded. Data will be collected for patients who have undergone PED-TAE using the TriNav Infusion System at participating sites. The registry study will include up to 10 sites, with Sarasota Memorial Health Care System acting as the lead site responsible for maintaining and monitoring the study database.
Key Details
Gender
All
Age Range
18 Years - 89 Years
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2025-04-01
Completion Date
2028-04-01
Last Updated
2025-09-08
Healthy Volunteers
No
Conditions
Interventions
Data Collection
Subjects with planned PED-TAE delivered via TriNav will receive their treatment following routine standard of care procedures. Post-procedural data obtained by a patient chart review will be collected in a study database. No additional study-specific interventions or visits outside of the routine clinical treatment will be performed.
Locations (1)
Sarasota Memorial Health Care System
Sarasota, Florida, United States