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
NA
30 participants
INTERVENTIONAL
2019-06-10
2019-09-01
Brief Summary
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3\. Biopsy core length obtained (i.e. collecting all tissue fragments) 4. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)
Detailed Description
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* Biopsy cores will be collected from the breast during US guided biopsy procedure.
* The number of cores taken will be decided per the physician discretion according to the clinical demand.
* Additional two biopsy core will be taken the SmartBx cassette. Since the SmartBx cassette holds two biopsies together, two consecutive cores will be collected using the SmartBx.
* samples will be photographed for measurements in 2 steps during the process:
1. On the needle notch \[A\].
2. On the glass slide \[B\].
* Standard tissue fixation, processing of the samples in paraffin will be performed unchanged per the pathology laboratory protocols.
* Embedding of the biopsy cores taken with the SmartBx will be embedded using the SmartBx mold and tamper.
* Standard staining and histology analysis will be preformed to the sectioned samples, unchanged per the pathology protocols.
• Analysis will be preformed to the histological results, and a comparison between the standard procedures samples to the SmartBx samples will be performed in terms of -
* Biopsy core length obtained (i.e. collecting all tissue fragments)
* Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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SmartBx biopsy collection
* Biopsy cores will be collected from the breast during US guided biopsy procedure.
* The number of cores taken will be decided per the physician discretion according to the clinical demand.
* Additional two biopsy core will be taken the SmartBx cassette
SmartBx
he SmartBx device is intended for the retention of a biopsy specimen and for preservation of the specimen's in-needle location and orientation.
The SmartBx is used as an aiding tool in biopsy procedures. When operated in conjunction with the standard equipment in a prostate biopsy procedure, the SmartBx may be used for the following:
* To preserve sample unity, including core fragments in their original location along the needle notch.
* Avoid sample damaging during sample removal from the needle and the following pathology process.
Interventions
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SmartBx
he SmartBx device is intended for the retention of a biopsy specimen and for preservation of the specimen's in-needle location and orientation.
The SmartBx is used as an aiding tool in biopsy procedures. When operated in conjunction with the standard equipment in a prostate biopsy procedure, the SmartBx may be used for the following:
* To preserve sample unity, including core fragments in their original location along the needle notch.
* Avoid sample damaging during sample removal from the needle and the following pathology process.
Eligibility Criteria
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Inclusion Criteria
* Planned for breast biopsy procedure.
* Signed informed consent.
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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UC Care, Ltd.
INDUSTRY
Responsible Party
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Locations
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Haemek medical center
Afula, North Region, Israel
Countries
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Other Identifiers
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EMC-0124-18
Identifier Type: -
Identifier Source: org_study_id