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 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
NCT ID:
NCT06868459
Eligibility Criteria:
Inclusion Criteria:
1. Adults, 18 years and or older and 89 years or younger
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 or \>89 years old
5. Graves' disease or inflammatory thyroiditis (Hashimoto's) or other condition with the presence of an extensive collateral network as demonstrated or initial angiography
6. Presence of a bovine arch or any other anatomical variant with no inferior thyroid artery present
7. Prior thyroid thermal ablation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT06868459
Study Brief:
Protocol Section:
NCT06868459