Clinical Trial

Pressure-enabled Retrograde Occlusive Therapy With Embolization for Control of Thyroid Disease (PROTECT Registry): A Multicenter Registry

Enrolling by Invitation
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-03-05; most recent amendment 2025-09-01.
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-07-18
Trial Details
NCT Number NCT06868459
Lead Sponsor Sarasota Memorial Health Care System
Collaborators: TriSalus Life Sciences, Inc.
Conditions Hyperthyroidism; Goiter, Multinodular Goiter, Thyroid Nodules, Thyroid Disease, Hyperthyroidism, Toxic Multinodular Goiter
Enrollment 100 participants
Start Date 2025-04-01
Primary Completion 2027-04-01 (estimated)
Study Completion 2028-04-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-08