- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01463709
Development of a Nanosecond Pulsed Electric Field System to Treat Skin Cancer (NPEF)
February 19, 2013 updated by: UCSF Benioff Children's Hospital Oakland
Human Basal Cell Carcinomas (BCCs) can be ablated by treating them with nanosecond pulsed electric fields (nsPEF)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Oakland, California, United States, 94609
- Children's Hospital Research Center Oakland
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Study subjects must have had diagnosed at least one BCCon their trunk
- The subject is from 18-75 years of age, inclusive.
- The subject must sign and date all informed consent statements.
Exclusion Criteria:
- The subject is exhibiting signs of a bacterial or viral infection, including fever.
- The subject is unwilling to allow a biopsy of a malignant lesion for histological analysis.
- The subject has a pace maker or other electronic device implanted
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: nanopulse
Administer nano pulse to lesion for varying time intervals.
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ervin E Epstein, MD, Children's Hospital Research Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
October 26, 2011
First Submitted That Met QC Criteria
October 31, 2011
First Posted (Estimate)
November 2, 2011
Study Record Updates
Last Update Posted (Estimate)
February 21, 2013
Last Update Submitted That Met QC Criteria
February 19, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-049
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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