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

NCT ID: NCT01463709

Last Updated: 2013-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-06-30

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.

Conditions

Basal Cell Carcinomas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

nanopulse

Administer nano pulse to lesion for varying time intervals.

Group Type: EXPERIMENTAL

PulseCure pulse generator and Derm-pulse electrode

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

BioElectroMed

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ervin E Epstein, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Research Institute

Locations

Children's Hospital Research Center Oakland

Oakland, California, United States

Countries

United States

Other Identifiers

2011-049

Identifier Type: -

Identifier Source: org_study_id