Clinical Evaluation of Opto-Acoustic Image Quality With the Gen1B Duplex Probe in Breast Applications
NCT ID: NCT03845907
Last Updated: 2020-04-06
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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SUSPENDED
NA
4 participants
INTERVENTIONAL
2018-12-19
2020-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Imagio Gen 1B
Gen 1B duplex probe ultrasound / optoacoustic imaging of the breast and axillary lymph node, with the IMAGIO System and the Gen1B duplex probe
Gen 1B
Diagnostic Ultrasound and Optoacoustic Imaging
Gen 1
Diagnostic Ultrasound and Optoacoustic Imaging
Imagio Gen 1
Gen 1 duplex probe ultrasound / optoacoustic imaging of the breast and axillary lymph node, with the IMAGIO System
Gen 1B
Diagnostic Ultrasound and Optoacoustic Imaging
Gen 1
Diagnostic Ultrasound and Optoacoustic Imaging
Interventions
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Gen 1B
Diagnostic Ultrasound and Optoacoustic Imaging
Gen 1
Diagnostic Ultrasound and Optoacoustic Imaging
Eligibility Criteria
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Inclusion Criteria
* Is at least 18 years of age.
* Is willing to undergo an Imagio imaging evaluation and standard Ultrasound Evaluation of the breast and axillary lymph nodes.
* Is willing and able to comply with protocol-required scans.
Exclusion Criteria
* Has a condition or impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, breast implants within the previous 12 months, etc.) where the duplex probe will come in contact with the subject, which could interfere with the intended field of view.
* Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline.
* Is currently undergoing phototherapy.
* Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or undergoing treatment for a photosensitive disease and is experiencing photosensitivity.
* Has had an adverse reaction in the past to medical laser procedures, such as laser hair removal or laser tattoo removal.
* Has had a history of contact dermatitis induced by gold or chrome metal contact with skin.
* Has an acute or chronic hematoma and/or acute ecchymosis of the breast.
* Has had prior benign excisional breast biopsy within the past 18 months.
* Has nipple rings that cannot be removed or are not removed during Imagio evaluation.
* Currently has mastitis.
* Has focal pain in the breast.
18 Years
FEMALE
Yes
Sponsors
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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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Seno Medical
San Antonio, Texas, United States
Countries
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Other Identifiers
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GEN1B-01
Identifier Type: -
Identifier Source: org_study_id
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