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

Basal Cell Carcinomas Clinical Trial

— NPEF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463709
• Other study ID #: 2011-049
• Status: Completed
• Phase: Phase 1
• First received: October 26, 2011
• Last updated: February 19, 2013
• Start date: October 2011
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: Children's Hospital & Research Center Oakland
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Basal Cell Carcinomas
• Carcinoma, Basal Cell

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital Research Center Oakland	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital & Research Center Oakland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate the safety of PulseCure pulse generator and NanoBlate electrode and identify the optimal pulse number for treating basal cell carcinomas.	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.	One year	Yes
Secondary	Determine the efficacy of the PulseCure pulse generator using the optimal pulse number.	2. Conduct a non-significant risk Pilot Clinical Trial treating BCCs on the trunk of 20 patients with sporadic BCCs using the optimal pulse number determined from the feasibility trial to assess the efficacy of this technique.	one year	No