Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode System

Korábbi kezelés

• Participant had previous neck irradiation
• Selected nodule previously treated with radiofrequency ablation or ethanol. This does not apply to nodules previously treated with nanosecond Pulsed Field Ablation (nsPFA)
• Participant is pregnant at the time of screening or within 30 days prior to enrollment
• Use of any investigational device or drug within 30 days prior to enrollment that may confound the results of this study

Más betegség

• Participant has history of familial thyroid cancer in more than two first-degree relatives
• Participants currently suffering from a hematological disease or bleeding tendency
• Participant has a history of uncontrolled cardiac arrhythmia, uncontrolled hypertension, chronic liver disease or chronic kidney disease (Stage 4-5), or recent history of myocardial infarction or structural heart disease as determined by the Investigator
• Anesthesia drug allergies
• Participant has any condition or situation which, in the Investigator's opinion, puts the participant at significant risk, could confound the study results, or may interfere significantly with the participant's participation in the study

Egyéb

• Participant has an implantable electronic medical device. (i.e., pacemaker, implantable cardioverter defibrillator)
• Participant has cystic nodules (< 70% solid components)
• Participant has calcified nodules
• Participant is known to be immune compromised
• Participant has abnormal cervical lymph nodes present during screening visit examination
• Selected nodule likely to be in contact with the recurrent laryngeal nerve on ultrasound evaluation
• Participant has abnormal contralateral vocal cord function

• 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