Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/27/2019 |
| Start Date: | August 2016 |
| End Date: | March 2020 |
Subjects will be scanned on the QT Ultrasound Breast Scanner. For subjects that may have
breast calcifications and/or mass(es) and/or other finding(s) on the QT scan image(s),
standard imaging modalities (e.g., mammogram and HHUS) will be performed per ACR
recommendations.
If available, subjects may provide copies of their breast imaging exams and related reports.
Demographics and medical history will be collected.
breast calcifications and/or mass(es) and/or other finding(s) on the QT scan image(s),
standard imaging modalities (e.g., mammogram and HHUS) will be performed per ACR
recommendations.
If available, subjects may provide copies of their breast imaging exams and related reports.
Demographics and medical history will be collected.
Inclusion Criteria:
- At least 18 years old
- Willing and able to provide written, signed informed consent
- Willing and able to comply with all study procedures
Exclusion Criteria:
- Inability to tolerate the scan
- Present infection risk
- Allergies to device materials
- Inability to successfully "fit" breast into the investigational device
- Currently pregnant as reported by the subject
- Body weight greater than 400 lbs. (180 kg)
- Any other conditions that the Investigator determines to interfere with the conduct of
the study or evaluation of results
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