Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
165 participants
OBSERVATIONAL
2020-09-11
2023-07-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Imagio OA/US
Imagio optoacoustic
Imagio OA/US
Imagio optoacoustic
Interventions
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Imagio OA/US
Imagio optoacoustic
Eligibility Criteria
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Inclusion Criteria
2. Are females 18 years of age or older at the time of consent,
3. Have been referred for a breast US and are subject to treatment with the Imagio breast imaging system.
Exclusion Criteria
2. Have open sores including insect bites, rash, poison ivy, and chafing on the skin of the ipsilateral breast.
3. Are experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline.
4. Are currently undergoing phototherapy.
5. Have a history of any photosensitive disease (e.g., porphyria, lupus erythematosus).
6. Are undergoing treatment for a photosensitive disease and is experiencing photosensitivity.
7. Have previously participated in this registry,
8. Are currently enrolled in another investigational study or registry that would directly interfere with the current registry.
18 Years
FEMALE
Yes
Sponsors
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American College of Radiology
OTHER
Seno Medical Instruments Inc.
INDUSTRY
Responsible Party
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Locations
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Rijnstate Hospital
Arnhem, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Zorggroep Twente
Hengelo, , Netherlands
Countries
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Other Identifiers
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CONFIDENCE-01
Identifier Type: -
Identifier Source: org_study_id
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