Development of a Nanosecond Pulsed Electric Field System to Treat Skin Cancer
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Demonstrate the safety of PulseCure pulse generator and NanoBlate electrode and identify the optimal pulse number for treating basal cell carcinomas.
1. Conduct a non-significant risk feasibility clinical trial treating BCCs on the trunk of up to 9 Basal Cell Nevus Syndrome patients with BioElectroMed's PulseCure pulse generator and Derm-Pulse electrode to both demonstrate the safety of nsPEF therapy and identify the optimal pulse number for ablating BCCs.
Ervin E Epstein, MD
Children's Hospital Research Institute
United States: Institutional Review Board
|Children's Hospital Research Center Oakland||Oakland, California 94609|