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.
Full Title of Study: “Assessing the Sensitivity of “SureTouch™” in Identifying Clinically Significant Masses in Women Undergoing Diagnostic and Screening Mammography”
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Screening
- Masking: Single (Participant)
- Study Primary Completion Date: June 1, 2022
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).
- Device: SureTouch
- The first group will consist of 70 women who are believed to be free of masses, recruited during a screening mammography appointment. The second group will include 125 women presenting for diagnostic mammography and/or biopsy appointment with known masses identified on mammogram, ultrasound or both. Both groups will receive breast cancer screening with mammography and SureTouch.
Arms, Groups and Cohorts
- Experimental: Subjects without messes
- Subjects who are believed to be free of masses.
- Experimental: Subjects with known masses
- Subjects with known masses.
Clinical Trial Outcome Measures
- Time Frame: 2 years
- 1. This study examines the sensitivity of the SureTouch™ system, compared with methods that are the current standard of care (screening and diagnostic mammography with ultrasound), to detect clinically significant mass lesions in the breast.
- Time Frame: 2 years
- The study will determine the patient acceptance of and satisfaction with the SureTouch devise. Outcome measure will use a 9 question Likert scale survey to assess patient perception of the comfort, duration and acceptance of the SureTouch device.
Participating in This Clinical Trial
- Female Subject presenting for screening mammography
- 30-80 years of age, inclusive
- Able to provide written informed consent
- 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
- 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
- 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
Gender Eligibility: Female
Minimum Age: 30 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Rebecca Kaltman, MD
- Sure, Inc.
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Rebecca Kaltman, MD, Assistant Professor of Medicine – George Washington University
- Overall Contact(s)
- Christiane Morecock, 202-655-5955, firstname.lastname@example.org
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