Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT05003856
Eligibility Criteria:
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), calcitonin, and absence of anti-thyroglobulin antibodies (TgAb) and anti-thyroid peroxidase antibodies (TPOAb)
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05003856
Study Brief:
Protocol Section:
NCT05003856