Assessing the Sensitivity of "SureTouch " in Identifying Clinically Significant Masses in Women Undergoing Diagnostic and Screening Mammography
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- STATUS
- Recruiting
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- participants needed
- 195
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- sponsor
- Rebecca Kaltman, MD
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 | 30-80 years |
| Treatment | SureTouch |
| Clinical Study Identifier | NCT04397029 |
| Sponsor | Rebecca Kaltman, MD |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf 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.
Learn moreComplete 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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