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Spots Global Cancer Trial Database for Development of a Nanosecond Pulsed Electric Field System to Treat Skin Cancer

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Trial Identification

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

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

Study ID: NCT01463709

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Children's Hospital Research Center Oakland, Oakland, California, United States

Contact Details

Name: Ervin E Epstein, MD

Affiliation: Children's Hospital Research Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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