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

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ClinicalTrials.gov Identifier: NCT01463709
Recruitment Status : Completed
First Posted : November 2, 2011
Last Update Posted : February 21, 2013
Sponsor:
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland

October 26, 2011
November 2, 2011
February 21, 2013
October 2011
June 2012   (Final data collection date for primary outcome measure)
Demonstrate the safety of PulseCure pulse generator and NanoBlate electrode and identify the optimal pulse number for treating basal cell carcinomas. [ Time Frame: 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.
Demonstrate the safety of PulseCure pulse generator and Derm-Pulse electrode and identify the optimal pulse number for treating basal cell carcinomas. [ Time Frame: 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.
Complete list of historical versions of study NCT01463709 on ClinicalTrials.gov Archive Site
Determine the efficacy of the PulseCure pulse generator using the optimal pulse number. [ Time Frame: 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.
Same as current
Not Provided
Not Provided
 
Development of a Nanosecond Pulsed Electric Field System to Treat Skin Cancer
Development of a Nanosecond Pulsed Electric Field System to Treat Skin Cancer
Human Basal Cell Carcinomas (BCCs) can be ablated by treating them with nanosecond pulsed electric fields (nsPEF)
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.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Basal Cell Carcinomas
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

Other Name: BioElectroMed
Experimental: nanopulse
Administer nano pulse to lesion for varying time intervals.
Intervention: Device: PulseCure pulse generator and Derm-pulse electrode
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
26
June 2012
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01463709
2011-049
No
Not Provided
Not Provided
Children's Hospital & Research Center Oakland
Children's Hospital & Research Center Oakland
Not Provided
Principal Investigator: Ervin E Epstein, MD Children's Hospital Research Institute
Children's Hospital & Research Center Oakland
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP