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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: First Sense Medical®

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.

• Study Type: Observational
• Enrollment (Actual): 358

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43614
      • Eleanor N. Dana Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The study population is comprised of adult women who are having a diagnostic or screening mammogram.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
First Sense Breast Exam	Device: First Sense Medical®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of breast cancer cases detected by the new medical device (the First Sense Medical technology)	Up to 12 months

Collaborators and Investigators

• Sponsor: First Sense Medical, LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): October 21, 2016
• Study Completion (Actual): October 21, 2016

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: December 16, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Actual): December 11, 2017
• Last Update Submitted That Met QC Criteria: December 7, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: FSM-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No