Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS
Not Applicable
- Conditions
- Volunteer Subjects
- Interventions
- Other: QT Ultrasound Breast Scan
- Registration Number
- NCT02948361
- Lead Sponsor
- QT Ultrasound LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1500
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description QT Ultrasound breast scan QT Ultrasound Breast Scan -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Marin Breast Health Trial Center
🇺🇸Novato, California, United States