Radiofrequency Ablation for the Treatment of Benign or Low Risk Thyroid Nodule

Inclusion Criteria

• Patient is older than 18 years, is not a surgical candidate or refuses to have surgery
• Patient is medically fit to undergo local anesthesia with or without conscious sedation
• Patient is able to understand and give consent to participation in the study
• Presence of compression symptoms or cosmetic concerns for which patient request treatment of the benign thyroid nodule
• Solitary thyroid nodule or dominating nodule that is well-defined in multinodular goiter
• Benign nodule is >= 2 cm in the largest dimension, and has either solid, or predominantly solid composition (>= 70% volume) without large calcification. Nodule is confirmed as benign (Bethesda II) on at least 2 ultrasound guided fine needle aspirations (FNA) or core needle biopsy (CNB) or a single benign diagnosis of FNA or CNB when the nodule has benign ultrasound features (American College of Radiology [ACR] Thyroid Imaging Reporting & Data System [TI-RAD] TR 1-3, American Thyroid Association [ATA] very low suspicion) within 6 months of planned RFA
• Indeterminate thyroid nodule (atypical cells of undetermined significance [ACUS], follicular neoplasm), papillary thyroid carcinoma (PTC) without metastasis or locally recurrent thyroid cancer < 2 cm in the largest dimension. Nodule cytology is confirmed on a single FNA or CNB when the nodule has concordant ultrasound features (ACR TI-RAD TR 4-5, ATA intermediate-high suspicion) within 6 months of planned RFA
• Entirety of the selected nodule is visible on ultrasound without significant extension posterior to trachea or mediastinal component
• Selected nodule is amenable to trans-isthmus approach
• Normal complete blood count, blood coagulation, serum levels of thyroid hormones, thyrotropin (TSH)
• Patient agrees to participate in the clinical study and to complete all required visits and evaluations
• Negative serum or urine pregnancy test for females of childbearing potential at base line pre-procedure evaluation

Exclusion Criteria

• Patients with cardiac arrhythmia and/or implanted cardiac device
• Hyper-functioning nodules, evaluated by thyroid function test and/or 99mTc-pertechnetate scintigraphic findings
• History of neck radiation therapy
• Pregnancy
• Allergies to medications for anesthesia
• Primary thyroid PTC with aggressive histology (tall cell, columnar cell, insular, e.g.) in consultation with cytology, endocrine and surgery team
• Extra-thyroidal invasion of PTC OR local nodal/distant systemic metastatic disease
• Cystic nodules (< 70% solid components)
• Calcified nodules
• Targeted nodule within 0.5 cm from the major vessels, vagus nerve, brachial plexus, and recurrent laryngeal nerve
• Patients with contralateral vocal cord paralysis
• Uncorrectable coagulopathy with partial thromboplastin time (PTT) > 1.5 x upper limit of normal (ULN) or international normalized ratio (INR) > 1.5 or platelet count <100,000 per mm^3