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ENROLLING BY INVITATION
NCT06868459

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

Sponsor: Sarasota Memorial Health Care System

View on ClinicalTrials.gov

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

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.

Locations (1)

Sarasota Memorial Health Care System

Sarasota, Florida, United States