Trial record 1 of 3 for:
BR004
Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS (PROGRESS)
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ClinicalTrials.gov Identifier: NCT02948361 |
Recruitment Status :
Active, not recruiting
First Posted : October 28, 2016
Last Update Posted : April 22, 2022
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Sponsor:
QT Ultrasound LLC
Information provided by (Responsible Party):
QT Ultrasound LLC
Tracking Information | |||
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First Submitted Date ICMJE | September 1, 2016 | ||
First Posted Date ICMJE | October 28, 2016 | ||
Last Update Posted Date | April 22, 2022 | ||
Study Start Date ICMJE | August 2016 | ||
Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS | ||
Official Title ICMJE | Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS | ||
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. |
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Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Not Applicable | ||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Volunteer Subjects | ||
Intervention ICMJE | 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.
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Study Arms ICMJE | Experimental: QT Ultrasound breast scan
Intervention: Other: QT Ultrasound Breast Scan
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Active, not recruiting | ||
Estimated Enrollment ICMJE |
1500 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Estimated Study Completion Date ICMJE | December 2022 | ||
Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02948361 | ||
Other Study ID Numbers ICMJE | BR004 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE |
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Current Responsible Party | QT Ultrasound LLC | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | QT Ultrasound LLC | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | QT Ultrasound LLC | ||
Verification Date | April 2022 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |