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
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Carcinomas||Device: PulseCure pulse generator and Derm-pulse electrode||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development of a Nanosecond Pulsed Electric Field System to Treat Skin Cancer|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Administer nano pulse to lesion for varying time intervals.
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463709
|United States, California|
|Children's Hospital Research Center Oakland|
|Oakland, California, United States, 94609|
|Principal Investigator:||Ervin E Epstein, MD||Children's Hospital Research Institute|