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A Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions (Dermacorder)

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ClinicalTrials.gov Identifier: NCT01014819
Recruitment Status : Completed
First Posted : November 17, 2009
Last Update Posted : August 3, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The Dermacorder measures the electric field in the skin. Malignant skin lesions disrupt the skin's normal electric field and this abnormal electric field can be detected by the Dermacorder. Therefore the investigators are testing the hypothesis that the Dermacorder can provide useful data to guide in the diagnosis of skin disease.

Condition or disease
Basal Cell Carcinoma

Detailed Description:
The Dermacorder is a non-invasive medical device that scans a probe over the skin about 200 microns away from it and detects the electric field in the skin using capacitative coupling. Measurements of hundreds of malignant melanomas in mice indicated that these lesions generate an electric field that is easily detected. One previous clinical trial at the VA Medical Center in Hampton VA indicated an 80% reliability in predicting malignant lesions by their electric field. We have improved the Dermacorder over the past two years by enhancing its sensitivity and stability and must now determine if these improvements have improved its ability to detect malignant lesions. If the Dermacorder provides a reliable diagnosis of malignant lesions, its use could dramatically reduce the number of biopsies performed and this would significantly improve the quality of life for hundreds of thousands of Americans seeking the advice of dermatologists regarding suspicious lesions each year

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Phase I Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions
Study Start Date : October 2009
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Males and females with multiple basal cell carcinomas
Criteria

Inclusion Criteria:

  • Study subjects must have had diagnosed at least one benign or malignant skin lesion;
  • Subject is from 18-75 years of age, inclusive;
  • Subject must sign and date all informed consent statements.

Exclusion Criteria:

  • Subject is exhibiting signs of a bacterial or viral infection, including fever;
  • Subject is unwilling to allow a biopsy of a malignant lesion for histological analysis.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01014819


Locations
United States, California
Childrens Hospital Oakland Research Institute
Oakland, California, United States, 94609
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Investigators
Principal Investigator: Ervin Epstein, M.D. Children's Hospital & Research Center Oakland
More Information

Responsible Party: Ervin Epstein, MD Scientist, Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT01014819     History of Changes
Other Study ID Numbers: 2009-36
First Posted: November 17, 2009    Key Record Dates
Last Update Posted: August 3, 2011
Last Verified: August 2011

Keywords provided by Children's Hospital & Research Center Oakland:
Dermacorder
Electric field
basal cell carcinoma
Gorlin Syndrome

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell