Sarasota Memorial Health Care System
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.
Inclusion Criteria: 1. Adults, 18 years and or older and 89 years or younger 2. Having undergone PED-TAE using the TriNav Infusion System 3. Meeting one of the following criteria: 1. Documented subclinical and or clinical hyperthyroidism in the presence of a toxic multinodular goiter or a toxic nodule \> 20 ml 2. Patients' ineligible or refusing surgery, radio-iodine therapy or percutaneous ablation 3. Non-functioning multinodular goiters or nodule causing compressive symptoms including but not limited to neck pain, dysphagia, stridor, exercise induced dyspnea and/or pressure sympto…
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.