Nanosecond Pulse Electric Field Ablation for the Treatment of Papillary Thyroid Cancer

Inclusion Criteria

• Participant must be at least 18
• Participant who is not candidate for surgery or who prefers less aggressive management. Participant must provide voluntary, written informed consent to participate in this clinical investigation
• Participant agrees to comply with all study procedures, including all follow-up visits
• Participant with a Bethesda VI cytology or Bethesda V cytology with a BRAF V600E mutation (tumor size <= 1.5 cm, no known regional/distant metastases)
• Ultrasonographic evaluation of tumor to be ablated must show size of less than or equal to 1.5 cm and no extrathyroidal extension or locoregional metastases
• Participant must have no clinically significant abnormalities in complete blood count, coagulation parameters, or thyroid function tests that, in the opinion of the investigator, would increase procedural risk or interfere with study assessments
• For females of childbearing potential, a negative serum or urine pregnancy test must be obtained at baseline, prior to the procedure

Exclusion Criteria

• Fine needle aspiration (FNA) findings suggestive of high-grade malignancy, including poorly differentiated or anaplastic thyroid carcinoma, as well as findings suspicious for follicular carcinoma
• Presence of regional or distant lymph node metastases
• Participant had a history of previous neck irradiation
• Females who are pregnant at time of enrollment
• Participant has any condition or situation, in the opinion of the site investigator, that puts the subject at significant risk, could confound the study results, or may interfere significantly with subject’s participation in the study