A Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions
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Purpose
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 |
|---|
|
Basal Cell Carcinoma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | A Phase I Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2009 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
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
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Males and females with multiple basal cell carcinomas
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| United States, California | |
| Childrens Hospital Oakland Research Institute | |
| Oakland, California, United States, 94609 | |
| Principal Investigator: | Ervin Epstein, M.D. | Children's Hospital & Research Center Oakland |
More Information
No publications provided
| 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 |
| Study First Received: | November 16, 2009 |
| Last Updated: | August 2, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital & Research Center Oakland:
|
Dermacorder Electric field basal cell carcinoma Gorlin Syndrome |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Basal Cell Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Basal Cell |
ClinicalTrials.gov processed this record on May 16, 2013