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OpenTrials
Enrolling by Invitation

NCT Number: NCT02948361

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

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.

Enrolling by Invitation

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Key information

Conditions

Volunteer Subjects

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Marin Breast Health Trial Center

Novato, California, 94949, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QT Ultrasound Breast Scan

Other

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.

Primary outcomes

  1. QT Ultrasound scans

    Time frame: 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

Sponsors and collaborators

Lead sponsor

QT Ultrasound LLC

Industry

Registry information

Acronym: PROGRESS

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Oct 28, 2016
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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