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

StatusEnrolling by Invitation
PhaseNot specified
Started

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Record History

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  1. Trial sites expanded: 1 → 4 locations
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Publications: details revised at 14 of 14 entries
  2. Eligibility criteria expanded, about 52 wordsv4
  3. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Site contact updated
    v3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06868459
Lead Sponsor Sarasota Memorial Health Care System
Collaborators: TriSalus Life Sciences, Inc.
Conditions
(from sponsor)		 Hyperthyroidism; Goiter, Multinodular Goiter, Thyroid Nodules, Thyroid Disease, Hyperthyroidism, Toxic Multinodular Goiter
Related terms Goiter, Hyperthyroidism, Thyroid Diseases, Thyroid Nodule
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov