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

Launched by SARASOTA MEMORIAL HEALTH CARE SYSTEM · Mar 5, 2025

Keywords

ClinConnect Summary

The PROTECT Registry is a clinical trial designed to study a new treatment approach for patients with certain thyroid conditions, such as hyperthyroidism and goiter. Specifically, this trial will look at how effective a procedure called pressure-enabled delivery of thyroid embolization (PED-TAE) is for improving patients' quality of life. The procedure involves using a special system to block blood flow to problematic areas in the thyroid gland, which may help reduce symptoms and improve overall thyroid health. The study will gather information from multiple healthcare centers, with Sarasota Memorial Health Care System leading the efforts.

To participate in this trial, individuals must be 18 years or older and have undergone the PED-TAE procedure. Eligible participants may include those with diagnosed hyperthyroidism or goiter who cannot or choose not to have surgery or other traditional treatments. Participants will be monitored for their thyroid function, recovery, and any complications after the procedure. It's important to note that this trial is not currently recruiting participants, but it aims to gather valuable information that could help many people with thyroid diseases in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults, 18 years and older
• • 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 symptoms
• • 4. 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
• Exclusion Criteria:
• • 1. Renal insufficiency
• • 2. Unable to tolerate angiography including pregnancy and severe allergy to contrast media
• • 3. Bethesda 4-6 on FNAB (suspicious for follicular neoplasm, suspicious for malignancy, or malignant)
• • 4. \<18 years old