Study Results
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View full resultsBasic Information
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COMPLETED
NA
155 participants
INTERVENTIONAL
2018-11-13
2018-12-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
Imagio (IUS+OA) Training to be completed prior to any reads taking place. Read 1 is immediately followed by Read 2 within the same read session.
Read 1 (Control): Mammogram (if available) + History + IUS (stills and videos provided), IUS Probability of Malignancy (POM) and BI-RADS scored and the data form locked.
Read 2 (Test): Mammogram (if available) + History + IUS (stills and videos provided), and Imagio (IUS+OA) (stills and videos provided). An interim IUS POM and BI-RADS is recorded as well as a combined Imagio (IUS+OA) POM and BIRADS Pre and Post SenoGram on separate data forms.
DIAGNOSTIC
SINGLE
Study Groups
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Imagio IUS
Read 1 - Mammo (as available) + Imagio Ultrasound
Imagio Ultrasound
Imagio ultrasound images to be reviewed as part of the reader study
Mammography
Mammography images as available per standard of care
Imagio (IUS+OA)
Read 2 - Mammo (as available) + (Imagio Ultrasound + OA)
Imagio (IUS+OA)
The Imagio ultrasound and opto-acoustic images to be reviewed as part of the reader study
Mammography
Mammography images as available per standard of care
Interventions
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Imagio (IUS+OA)
The Imagio ultrasound and opto-acoustic images to be reviewed as part of the reader study
Imagio Ultrasound
Imagio ultrasound images to be reviewed as part of the reader study
Mammography
Mammography images as available per standard of care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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American College of Radiology
OTHER
Seno Medical Instruments Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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A. Thomas Stavros, MD
Role: STUDY_DIRECTOR
Seno Medical
Locations
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American College of Radiology
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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Reader-01
Identifier Type: -
Identifier Source: org_study_id
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