Assessing the Sensitivity of "SureTouch " in Identifying Clinically Significant Masses in Women Undergoing Diagnostic and Screening Mammography

  • STATUS
    Recruiting
  • participants needed
    195
  • sponsor
    Rebecca Kaltman, MD
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Updated on 5 August 2020
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screening mammography

Summary

Prospective, case-control study being conducted to determine the sensitivity of the SureTouch device in detecting known masses at a pre-determined level of specificity.

Description

This is a single-center, prospective, case-control study being conducted to determine the sensitivity of the SureTouch device in detecting known masses at a pre-determined level of specificity.

Results of the mammography will be compared to the SureTouch examination results.

Subjects will have between 1 and 3 research visits and 3 follow-up surveys, up to two years from the initial visit. The number of visits will be based upon comparison of the SureTouch examination to conventional breast screening techniques (mammogram and ultrasound).

Details
Condition Breast Cancer, Breast Cancer
Age 30years - 80years
Treatment SureTouch
Clinical Study IdentifierNCT04397029
SponsorRebecca Kaltman, MD
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Arm 1
Female Subject presenting for screening mammography
-80 years of age, inclusive
Able to provide written informed consent
Arm 2
Female Subject presenting for diagnostic appointment and/or biopsy
-80 years of age, inclusive
-3 masses per breast
Masses between 0.5 cm and 3.5 cm only

Exclusion Criteria

Individuals who are unable to comprehend or unwilling to sign an informed consent form
Women younger than 30 or older than 80
Pregnant women
Women who have undergone bilateral mastectomies
Males
Prisoners
Masses which are larger than 3.5 cm or smaller than 0.5 cm in size
Individuals with more than 3 masses per breast will be excluded due to the complexity of these cases
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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