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

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02633605

Run by

First Sense Medical, LLC

People needed

358

Starts

2016-01-01

Expected to finish

2016-10-21

Last updated by the study team

2017-12-11

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Eleanor N. Dana Cancer Center — Toledo, Ohio, United States

Full record on ClinicalTrials.gov

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