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Completed

NCT Number: NCT02633605

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Eleanor N. Dana Cancer Center

Toledo, Ohio, 43614, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

First Sense Medical®

Device

Primary outcomes

  1. Percentage of breast cancer cases detected by the new medical device (the First Sense Medical technology)

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

First Sense Medical, LLC

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2015
Registry last updated
Dec 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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