Assessing the Sensitivity of "SureTouch™" in Women Undergoing Diagnostic and Screening Mammography

Stopped early · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT04397029

Run by

George Washington University

People needed

213

Starts

2019-01-04

Expected to finish

2021-02-10

Last updated by the study team

2022-06-13

Who can join

Age: 30 and older, up to 80. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• George Washington University - Medical Faculty Associates — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.