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


Phase 1
18 Years
75 Years
Not Enrolling
Both
Basal Cell Carcinomas

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Demonstrate the safety of PulseCure pulse generator and NanoBlate electrode and identify the optimal pulse number for treating basal cell carcinomas.

Outcome Description:

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.

Outcome Time Frame:

One year

Safety Issue:

Yes

Principal Investigator

Ervin E Epstein, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital Research Institute

Authority:

United States: Institutional Review Board

Study ID:

2011-049

NCT ID:

NCT01463709

Start Date:

October 2011

Completion Date:

June 2012

Related Keywords:

  • Basal Cell Carcinomas
  • basal cell carcinoma
  • Basal Cell Nevus Syndrome
  • Electric Field
  • Nanosecond pulse
  • Carcinoma
  • Skin Neoplasms
  • Carcinoma, Basal Cell

Name

Location
Children's Hospital Research Center Oakland Oakland, California  94609