Status:
TERMINATED
Assessing the Sensitivity of "SureTouch™" in Women Undergoing Diagnostic and Screening Mammography
Lead Sponsor:
George Washington University
Collaborating Sponsors:
Sure, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
30-80 years
Phase:
NA
Brief 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.
Detailed 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. Resul...
Eligibility Criteria
Inclusion
- Arm 1:
- Female Subject presenting for screening mammography
- 30-80 years of age, inclusive
- Able to provide written informed consent
- Arm 2:
- Female Subject presenting for diagnostic appointment and/or biopsy
- 30-80 years of age, inclusive
- 1-3 masses per breast
- Masses between 0.5 cm and 3.5 cm only
Exclusion
- 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
Key Trial Info
Start Date :
January 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2021
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT04397029
Start Date
January 4 2019
End Date
February 10 2021
Last Update
June 13 2022
Active Locations (1)
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1
George Washington University - Medical Faculty Associates
Washington D.C., District of Columbia, United States, 20037