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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02633605
• Other study ID #: FSM-002
• Status: Completed
• Phase: N/A
• First received: December 15, 2015
• Last updated: December 7, 2017
• Start date: January 2016
• Est. completion date: October 21, 2016

Study information

• Verified date: December 2017
• Source: First Sense Medical, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: October 21, 2016
• Est. primary completion date: October 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• First Sense Medical®

Locations

Country	Name	City	State
United States	Eleanor N. Dana Cancer Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
First Sense Medical, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of breast cancer cases detected by the new medical device (the First Sense Medical technology)		Up to 12 months