Volunteer Subjects
Conditions
Brief summary
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.
Interventions
OTHERQT Ultrasound Breast Scan
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 American College of Radiology (ACR) recommendations.
Sponsors
QT Ultrasound LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QT Ultrasound scans | Scan session is 2 to 3 hours | The capabilities of the QT Ultrasound scanner will be measured by the review of the QT Ultrasound scans at the conclusion of each QT Ultrasound scan session |
Countries
United States
Outcome results
None listed