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A Phase I Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions


N/A
18 Years
75 Years
Not Enrolling
Both
Basal Cell Carcinoma

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Trial Information

A Phase I Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions


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


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Principal Investigator

Ervin Epstein, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Hospital & Research Center Oakland

Authority:

United States: Institutional Review Board

Study ID:

2009-36

NCT ID:

NCT01014819

Start Date:

October 2009

Completion Date:

July 2011

Related Keywords:

  • Basal Cell Carcinoma
  • Dermacorder
  • Electric field
  • basal cell carcinoma
  • Gorlin Syndrome
  • Carcinoma
  • Carcinoma, Basal Cell

Name

Location

Childrens Hospital Oakland Research Institute Oakland, California  94609