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A Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions

This study has been completed.
Sponsor:
Information provided by:
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT01014819
First received: November 16, 2009
Last updated: August 2, 2011
Last verified: August 2011

November 16, 2009
August 2, 2011
October 2009
July 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01014819 on ClinicalTrials.gov Archive Site
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A Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions
A Phase I Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions

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.

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

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Probability Sample

Males and females with multiple basal cell carcinomas

Basal Cell Carcinoma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01014819
2009-36
No
Ervin Epstein, MD Scientist, Children's Hospital & Research Center Oakland
Children's Hospital & Research Center Oakland
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Principal Investigator: Ervin Epstein, M.D. Children's Hospital & Research Center Oakland
Children's Hospital & Research Center Oakland
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP