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

UCSF Benioff Children's Hospital Oakland

Status and phase: Completed; Phase 1

Conditions: Basal Cell Carcinomas

Treatments: Device: PulseCure pulse generator and Derm-pulse electrode

Study type: Interventional

Funder types: Other

Identifiers

NCT01463709

2011-049

Details and patient eligibility

About

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

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Study subjects must have had diagnosed at least one BCCon their trunk
2. The subject is from 18-75 years of age, inclusive.
3. The subject must sign and date all informed consent statements.

Exclusion criteria

1. The subject is exhibiting signs of a bacterial or viral infection, including fever.
2. The subject is unwilling to allow a biopsy of a malignant lesion for histological analysis.
3. The subject has a pace maker or other electronic device implanted

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

nanopulse

Experimental group

Description:

Administer nano pulse to lesion for varying time intervals.

Treatment:

Device: PulseCure pulse generator and Derm-pulse electrode