PROTECT Registry for Thyroid Embolization
This study is a registry, meaning it collects information from patients who have already received a treatment called Pressure-enabled Retrograde Occlusive Therapy With Embolization (PED-TAE) using the TriNav Infusion System for thyroid conditions like hyperthyroidism or goiter. The goal is to understand how this treatment affects your quality of life and to gather information on its safety and effectiveness, such as how much the thyroid shrinks and changes in thyroid function. You might be able to join if you are between 18 and 89 years old and have already had PED-TAE with the TriNav system for hyperthyroidism or a large toxic nodule. The study will look at your quality of life using a questionnaire and track any side effects for 6 months after your procedure. The current recruitment status is unclear.
- Study design
- This is an observational study, meaning researchers will collect data from your medical records after you've had your treatment. It aims to include 100 participants.
- What's involved
- After your PED-TAE treatment, information from your patient charts will be collected in a study database. You will also complete a quality of life questionnaire.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your quality of life and any procedure-related side effects will be tracked for 6 months after your treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pressure-enabled Retrograde Occlusive Therapy With Embolization for Control of Thyroid Disease (PROTECT Registry): A Multicenter Registry
At a glance
Conditions
NCT06868459
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Sarasota Memorial Health Care System
Sarasota, Floridano site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Tamela Fonseca, PhD, RN, CCRC, NE-BC · STUDY_DIRECTOR · Sarasota Memorial Health Care System
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- ThyPro-39 questionnaire6 months
Change in quality of life as measured by ThyPro-39 questionnaire at 6-months (+/- 60). Responses to each statement are measured on a Likert scale ranging from '0= no symptoms or problems' to '4= severe symptoms or problems' based on the period of the last 4 weeks. Higher scores indicate greater impact on quality of life due to thyroid issues.
- Procedure related adverse events6 months
Safety as measured by the rate of procedure related adverse events as measured by SIR criteria at 2-weeks (+/- 7 days), 3- (+/- 30 days) and 6-months (+/- 60 days) post PED-TAE using TriNav treatment.