A Clinical Trial of Dermacorder for Detecting Malignant Skin Lesions

Basal Cell Carcinoma Clinical Trial

— Dermacorder  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014819
• Other study ID #: 2009-36
• Status: Completed
• Phase: N/A
• First received: November 16, 2009
• Last updated: August 2, 2011
• Start date: October 2009
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: Children's Hospital & Research Center Oakland
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma, Basal Cell

Locations

Country	Name	City	State
United States	Childrens Hospital Oakland Research Institute	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital & Research Center Oakland

Country where clinical trial is conducted

United States,