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Brief Title: Thermalogical Analysis of a Cohort of Women and Men Undergoing Mammographic Analysis.
Official Title: Thermalogical Analysis of a Cohort of Women and Men Undergoing Mammographic Analysis.
Study ID: NCT03271853
Brief Summary: This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan.
Detailed Description: FirstSense Medical, LLC is a medical device company which has developed a breast cancer screening device, the Sentinel BreastScan II \[SBS II\]. This radiation free device is being developed to produce data which will be analyzed by Therma-Scan Reference Laboratory. Dr. Hoekstra, CEO of Therma-Scan, is the author of a published paper based on breast thermal data with a reported 95% sensitivity and 91% specificity. The SBS II examination will take approximately 7 minutes. This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data by Therma-Scan. SBS II thermal breast data is an adjunctive aid to standard breast imaging. Currently, mammography is one of the standards of care in screening for visible signs of breast cancer. Breast thermology is the analysis of the heat signature data from an examined breast. All study costs will be incurred by the sponsor. Study subjects will incur no cost to participate. All scientific data revealed in this protocol will be used for the specific objectives of the study. The SBS II is a non-significant risk device. There is no contact with the subject during the entire procedure.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Eleanor N. Dana Cancer Center, University of Toledo, Toledo, Ohio, United States
Name: Haitham Elsamaloty
Affiliation: University of Toledo
Role: PRINCIPAL_INVESTIGATOR