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Comparison of First Sense Breast Exam® to the University of Toledo Mammography and Biopsy Results

2015-12-18 05:08:23 | BioPortfolio

Summary

First Sense Medical®, LLC is a medical device company developing a novel breast cancer screening tester called the First Sense Breast Exam® Tester. This radiation free tester is being developed to produce data which will be analyzed by Therma-Scan Reference Laboratory. When the tester is in production, a test will take approximately 7 minutes and will be performed in a doctor's office.

Description

This study is designed to evaluate the First Sense Breast Exam® test and the analysis by Therma-Scan. The First Sense Breast Exam® test is an adjunct to a mammogram. Currently, mammography is the standard of care in screening for breast cancer, and manual thermology is an adjunctive screening method. All of the study costs will be incurred by the sponsor and the subject will incur no costs to participate in the study. The First Sense Tester is a non-significant risk device where the tester's imaging camera makes no contact with the subjects during the entire procedure.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Conditions

Breast Cancer

Intervention

First Sense Medical®

Location

Eleanor N. Dana Cancer Center
Toledo
Ohio
United States
43614

Status

Not yet recruiting

Source

First Sense Medical, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-12-18T05:08:23-0500

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Medical and Biotech [MESH] Definitions

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