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

NCT ID: NCT02633605

Last Updated: 2017-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

358 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-10-21

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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First Sense Breast Exam

First Sense Medical®

Intervention Type DEVICE

Interventions

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First Sense Medical®

Intervention Type DEVICE

Eligibility Criteria

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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.

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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First Sense Medical, LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eleanor N. Dana Cancer Center

Toledo, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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FSM-002

Identifier Type: -

Identifier Source: org_study_id