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

First Sense Medical

Status: Completed

Conditions: Breast Cancer

Treatments: Device: First Sense Medical®

Study type: Observational

Funder types: Other

Identifiers

NCT02633605

FSM-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 358 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female, over the age of 18 years of age.
• Asymptomatic women and women who are being screened for breast abnormality.
• Women scheduled for a mammogram or women who have had a mammogram and are given 3 days to wait in between their mammogram and scheduled biopsy and FS/TS system.
• Not pregnant or breast feeding.
• Signed Informed consent.

Exclusion criteria

• Subject does not meet inclusion criteria, noted above.
• Use of niacin or niacin patch.
• Use of nitroglycerin.
• Subject experienced a fever of 102°F or higher within thirty-six (36) hours of the study.
• Patients with any prior breast surgery (implants, reduction, lumpectomy, mastectomy, mastopexy, reconstruction and incisional biopsies.).
• History of breast cancer

Trial design

358 participants in 1 patient group

First Sense Breast Exam

Treatment:

Device: First Sense Medical®