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

Enrolling by invitation

Conditions studied: Hyperthyroidism; Goiter, Multinodular Goiter, Thyroid Nodules, Thyroid Disease, Hyperthyroidism, Toxic Multinodular Goiter

In brief

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 facts

Study ID

NCT06868459

Run by

Sarasota Memorial Health Care System

People needed

100

Starts

2025-04-01

Expected to finish

2028-04-01

Last updated by the study team

2025-09-08

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults, 18 years and or older and 89 years or younger
• Having undergone PED-TAE using the TriNav Infusion System
• Meeting one of the following criteria:
• Documented subclinical and or clinical hyperthyroidism in the presence of a toxic multinodular goiter or a toxic nodule > 20 ml
• Patients' ineligible or refusing surgery, radio-iodine therapy or percutaneous ablation
• Non-functioning multinodular goiters or nodule causing compressive symptoms including but not limited to neck pain, dysphagia, stridor, exercise induced dyspnea and/or pressure symptoms
• Bethesda category 2-3 (benign, or atypia or follicular lesion of undetermined significance) on 2 separate fine-needle aspiration biopsy (FNAB) results with a benign molecular profile with patient declining surgical resection

You may not qualify if…

• Renal insufficiency
• Unable to tolerate angiography including pregnancy and severe allergy to contrast media
• Bethesda 4-6 on FNAB (suspicious for follicular neoplasm, suspicious for malignancy, or malignant)
• <18 years old or >89 years old
• Graves' disease or inflammatory thyroiditis (Hashimoto's) or other condition with the presence of an extensive collateral network as demonstrated or initial angiography
• Presence of a bovine arch or any other anatomical variant with no inferior thyroid artery present
• Prior thyroid thermal ablation

Where it is running

• Sarasota Memorial Health Care System — Sarasota, Florida, United States

Full record on ClinicalTrials.gov

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