Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System in Symptomatic Benign Thyroid Nodules (PRECISE-BTN) Study
The primary objective of this study is to reproduce in a multi-center study results obtained during the feasibility First-In-Human (FIH) study with Prof. Stefano Spiezia, MD (Ospedale del Mare, Naples, Italy) and to monitor additional thyroid-related symptoms and impact of patients quality of life post-ablation using a validated QoL questionnaire.
• Participant is willing and able to provide voluntary, written informed consent to participate in this study and from whom written informed consent has been obtained
• Participants must be willing and able to comply with study procedures including all follow-up visits
• Selected nodule is amenable to trans-isthmus approach
• Nodule is confirmed as benign based on results from one or more of the following diagnostic tests:
‣ (Bethesda II) on at least 2 ultrasound guided fine needle aspirations (FNA) or core needle biopsy (CNB);
⁃ 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\];
⁃ Candidate has a hyperfunctional nodule following 1 ultrasound guided FNA or CNB with or without molecular testing; or
⁃ Benign (Bethesda III or IV) with two biopsies in addition to molecular testing confirming benign diagnosis
• Selected nodule is \<80.0 ml
• Participant has normal vocal cord mobility by ultrasound evaluation
• Participant has presence of compression symptoms, cosmetic concerns or anxiety for which participant requests treatment of the benign thyroid nodule
• Participant has a solitary thyroid nodule or dominating nodule that is well-defined in multinodular goiter