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

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ClinicalTrials.gov Identifier: NCT02948361
Recruitment Status : Enrolling by invitation
First Posted : October 28, 2016
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
QT Ultrasound LLC

Study Description
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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.


Condition or disease Intervention/treatment Phase
Volunteer Subjects Other: QT Ultrasound Breast Scan Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS
Study Start Date : August 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: QT Ultrasound breast scan Other: QT 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.


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948361


Locations
United States, California
Marin Breast Health Trial Center
Novato, California, United States, 94949
Sponsors and Collaborators
QT Ultrasound LLC
Investigators
Study Director: Rajni Natesan, MD Chief Medical Officer
More Information
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Responsible Party: QT Ultrasound LLC
ClinicalTrials.gov Identifier: NCT02948361     History of Changes
Other Study ID Numbers: BR004
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No