Development of a Nanosecond Pulsed Electric Field System to Treat Skin Cancer — NPEF  

Basal Cell Carcinomas Clinical Trial

Official title: Development of a Nanosecond Pulsed Electric Field System to Treat Skin Cancer

Status Completed

Clinical Trial Summary

Human Basal Cell Carcinomas (BCCs) can be ablated by treating them with nanosecond pulsed electric fields (nsPEF)

Clinical Trial Description

The purpose of this study is to determine if low energy, non-thermal, 100 ns pulses can ablate BCCs. The investigators consider this a non-significant risk study because our PulseCure system only applies 0.4 watts to the skin compared to the 40 watts applied by the currently used electrosurgical unit to remove skin lesions, the Hyfrecator. Since the PulseCure applies 1/100 of the energy and does not even heat the skin significantly, it represents a non-significant risk to the patient. Our study will provide the first data on the response of BCCs to these 100 ns pulses. The investigators will first treat three BCCs on BCNS patients with different pulse numbers to determine the pulse number needed to ablate. Once the investigators have the optimal pulse number, the investigators will use it to treat 20 normal patients with sporadic BCCs on their trunks. This should provide sufficient data to conclude whether or not nsPEF can ablate BCCs on normal individuals. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Basal Cell Carcinomas
• Carcinoma, Basal Cell

• NCT number: NCT01463709
• Study type: Interventional
• Source: Children's Hospital & Research Center Oakland
• Status: Completed
• Phase: Phase 1
• Start date: October 2011
• Completion date: June 2012