Comparison of First Sense Breast Exam® to the University of Toledo Mammography and Biopsy Results
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 12/13/2017 |
| Start Date: | January 2016 |
| End Date: | October 21, 2016 |
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.
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.
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.
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.
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
We found this trial at
1
site
Toledo, Ohio 43614
Principal Investigator: Haitham Elsamaloty, PhD
Phone: 419-383-6962
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