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

Phase 1

Completed

• Conditions: Basal Cell Carcinomas
• Interventions: Device: PulseCure pulse generator and Derm-pulse electrode

• Registration Number: NCT01463709
• Lead Sponsor: UCSF Benioff Children's Hospital Oakland

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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-26
• Study First Submitted QC: 2011-10-31
• Study First Posted: 2011-11-02
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-19
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nanopulse	PulseCure pulse generator and Derm-pulse electrode	Administer nano pulse to lesion for varying time intervals.

Primary Outcome Measures

Name	Time	Method
Demonstrate the safety of PulseCure pulse generator and NanoBlate electrode and identify the optimal pulse number for treating basal cell carcinomas.	One year	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.

Secondary Outcome Measures

Name	Time	Method
Determine the efficacy of the PulseCure pulse generator using the optimal pulse number.	one year	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.

Trial Locations

Locations (1)

Children's Hospital Research Center Oakland; 🇺🇸 Oakland, California, United States