Development of a Nanosecond Pulsed Electric Field System to Treat Skin Cancer
Status: | Completed |
---|---|
Conditions: | Skin Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 2/4/2013 |
Start Date: | October 2011 |
End Date: | July 2014 |
Contact: | Joselyn Lindgren, MS |
Email: | jlindgren@chori.org |
Phone: | 510-450-7639 |
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.
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
We found this trial at
1
site
747 52nd St
Oakland, California 94609
Oakland, California 94609
(510) 428-3000
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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