A Phase 1 interventional study of PulseCure pulse generator and Derm-pulse electrode in Basal Cell Carcinomas, sponsored by UCSF Benioff Children's Hospital Oakland. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-21.
Sponsored by UCSF Benioff Children's Hospital Oakland · Phase 1, Interventional, and Treatment
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.
582 studies on the registry are indexed under Skin Neoplasms; 114 are open to participants now.
This study's enrollment of 4 is below the median of 53 across 416 interventional studies indexed under Skin Neoplasms.
Browse Skin Neoplasms studies →UCSF Benioff Children's Hospital Oakland is the lead sponsor of 53 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Also known as: BioElectroMed
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.
Time frame: One year
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.
Time frame: one year
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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UCSF Benioff Children's Hospital Oakland