NCT06117085

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

First Clinical Feasibility Study Using the CellFX® Percutaneous Electrode (PE) System for the Treatment of Symptomatic Benign Thyroid Nodules

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Pulse Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Thyroid Nodule (Benign)

Interventions

Type	Name	Description
DEVICE	CellFX® Percutaneous Electrode (PE) System	Percutaneous treatment with CellFX® Percutaneous Electrode using nanosecond pulse field ablation (nsPFA) technology

Timeline

• Start date: 2023-04-13
• Primary completion: 2024-11-18
• Completion: 2024-11-18
• First posted: 2023-11-03
• Last updated: 2024-11-21

Locations

1 site across 1 country: Italy