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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous Treatment Arm | Experimental | CellFX Percutaneous Treatment under ultrasound guidance using nanosecond Pulse Field Ablation (nsPFA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CellFX® Percutaneous Electrode (PE) System | Device | Percutaneous treatment with CellFX® Percutaneous Electrode using nanosecond pulse field ablation (nsPFA) technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with serious adverse device effects | The primary safety endpoint will be assessed by the incidence of serious adverse device effects | 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 | 6 months post-CellFX PE procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof Stefano Spiezia, MD | Chief of Endocrine and Ultrasound Guided Surgery, Operative Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale del Mare | ASLNA1 Centro | Naples | Italy |
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| ID | Term |
|---|---|
| D016606 | Thyroid Nodule |
| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| D006258 |
| Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |