CellFX ® Percutaneous Electrode (PE) Treatment of Symptomatic Benign Thyroid Nodules

Korábbi kezelés

• Participant has an active systemic infection on the day of the CellFX PE procedure with either fever, leukocytosis or requiring intravenous antibiotics or history of head and neck, pulmonary or systemic infection in the last 2 weeks prior to CellFX PE procedure
• Participant had previous neck irradiation
• Use of any other investigational drug, therapy, or device within 30 days prior to enrollment or concurrent participation in another research study

Más betegség

• Participant has history of familial thyroid cancer in more than two first-degree relatives
• Participants currently suffering from hematological diseases or bleeding tendency, or patients currently requiring continuous administration of antiplatelet and anticoagulant drugs
• Ultrasonographic evidence of calcifications, irregular margins or sonographic features that are suspicious for malignancy
• History of cardiac arrhythmia, uncontrolled hypertension, liver or kidney disease, or recent history of myocardial infarctions or structural heart disease as determined by the Investigator
• History of a coagulation mechanism disorder or bleeding tendency
• Allergy or contraindication to assigned analgesia/anesthesia
• Have 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 is known to be immune compromised
• Participant is a member of a vulnerable population including individuals employed by the Sponsor, clinic site, or entity associated with the conduct of the study
• Nodule likely to be in contact with the recurrent laryngeal nerve on ultrasound evaluation
• Abnormal contralateral vocal cord function
• Females of childbearing potential who are nursing, pregnant, or planning to become pregnant during the study period

• Participant must be at least 18 or no older than 80 years of age
• Participant gives voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
• Participant must comply with study procedures including all follow-up visits diagnosis of thyroid nodule confirmed by ultrasonography ≤Grade 3 (2017 ACR TI-RADS and fine needle aspiration biopsy FNA (Bethesda category II ) with no macro-calcifications in target nodule within 30 days of enrollment
• Participant has single nodule ≤ 6.0 cm in greatest dimension.
• Participant may have abnormal thyroid function, such as suppressed thyrotropin (TSH) levels, at the screening visit
• Participant has no abnormal cervical lymph nodes during screening visit examination
• Participant has thyroid nodule causing appearance, pressure or swallowing symptoms
• Participant has absence of abnormal vocal cord mobility by ultrasound evaluation