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

NCT06868459 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-09-08

No results posted yet for this study

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.

Conditions

  • Hyperthyroidism; Goiter
  • Multinodular Goiter
  • Thyroid Nodules
  • Thyroid Disease
  • Hyperthyroidism
  • Toxic Multinodular Goiter

Interventions

OTHER

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.

Sponsors & Collaborators

  • TriSalus Life Sciences, Inc.

    collaborator INDUSTRY

  • Sarasota Memorial Health Care System

    lead OTHER

Principal Investigators

  • Tamela Fonseca, PhD, RN, CCRC, NE-BC · Sarasota Memorial Health Care System

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2027-04-01
Completion
2028-04-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06868459 on ClinicalTrials.gov