NCT01463709

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: UCSF Benioff Children's Hospital Oakland · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Basal Cell Carcinomas

Interventions

Type	Name	Description
DEVICE	PulseCure pulse generator and Derm-pulse electrode	PulseCure 100 ns pulse generator: generates 30 kV/cm electric pulses 100 ns long to trigger apoptosis in cells between the electrodes. NanoBlate: Delivery device to treat 5 mm wide skin lesions with 100 ns pulses from PulseCure

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-11-02
• Last updated: 2013-02-21

Locations

1 site across 1 country: United States