NCT02633605

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 358 (actual)
• Sponsor: First Sense Medical, LLC · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	First Sense Medical®

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-10-21
• Completion: 2016-10-21
• First posted: 2015-12-17
• Last updated: 2017-12-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study