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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02633605

Enrollment

358

Registered

2015-12-17

Start date

2016-01-31

Completion date

2016-10-21

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief 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.

Interventions

DEVICEFirst Sense Medical®

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026