The objective of this clinical feasibility study is to evaluate initial clinical safety and device performance of the CellFX Percutaneous Electrode (PE) System for the treatment of symptomatic benign thyroid nodules.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* Participant has an implantable electronic medical device. (i.e., pacemaker, implantable cardioverter defibrillator)
* 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 is known to be immune compromised
* Participant is a member of a vulnerable population including individuals employ…
What they're measuring
1
Number of Participants with serious adverse device effects
Timeframe: 1 month, 3 months, 6 months and 12 months post-CellFX PE procedure
2
Number of Participants with Acute nodular volume loss