Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS (PROGRESS)

QT Imaging

Status: Unknown

Conditions: Volunteer Subjects

Treatments: Other: QT Ultrasound Breast Scan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02948361

BR004

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,500 participants in 1 patient group

QT Ultrasound breast scan

Experimental group

Treatment:

Other: QT Ultrasound Breast Scan