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Trial record 30 of 32 for:    "Nevoid basal cell carcinoma syndrome"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01463709
Recruitment Status : Completed
First Posted : November 2, 2011
Last Update Posted : February 21, 2013
Information provided by (Responsible Party):
UCSF Benioff Children’s Hospital Oakland

Brief Summary:
Human Basal Cell Carcinomas (BCCs) can be ablated by treating them with nanosecond pulsed electric fields (nsPEF)

Condition or disease Intervention/treatment Phase
Basal Cell Carcinomas Device: PulseCure pulse generator and Derm-pulse electrode Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Arm Intervention/treatment
Experimental: nanopulse
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01463709

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United States, California
Children's Hospital Research Center Oakland
Oakland, California, United States, 94609
Sponsors and Collaborators
UCSF Benioff Children’s Hospital Oakland
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Principal Investigator: Ervin E Epstein, MD Children's Hospital Research Institute

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Responsible Party: UCSF Benioff Children’s Hospital Oakland Identifier: NCT01463709     History of Changes
Other Study ID Numbers: 2011-049
First Posted: November 2, 2011    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013
Keywords provided by UCSF Benioff Children’s Hospital Oakland:
basal cell carcinoma
Basal Cell Nevus Syndrome
Electric Field
Nanosecond pulse
Additional relevant MeSH terms:
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Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases