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.
Cohort 1: (CellFX PE Procedure and Surgery) The first five enrolled subjects will be patients with planned thyroidectomy. The site investigator will perform the CellFX procedure followed by an ultrasound evaluation. The site investigator will then perform a partial or total thyroidectomy. Tissue samples from the CellFX targeted treated areas will be sent to the pathology lab for gross and histological evaluation. The participant will exit the study on the same day of surgery. Cohort 2: (CellFX PE Procedure with 12 months follow-up) When Cohort 1 is completed, up to 25 subjects will undergo a CellFX treatment using a percutaneous approach under ultrasound guidance. After CellFX treatment, all subjects will be followed weekly until 1 month, 3 months, 6 months and 12 months post-CellFX PE procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Percutaneous treatment with CellFX® Percutaneous Electrode using nanosecond pulse field ablation (nsPFA) technology
Ospedale del Mare | ASLNA1 Centro
Naples, Italy
Number of Participants with serious adverse device effects
The primary safety endpoint will be assessed by the incidence of serious adverse device effects
Time frame: 1 month, 3 months, 6 months and 12 months post-CellFX PE procedure
Number of Participants with Acute nodular volume loss
Acute procedural success defined as a ≥ 50% nodule volume loss by ultrasonography and without serious adverse device effects within 6-months of the procedure
Time frame: 6 months post-CellFX PE procedure
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