Evaluation of the SmartBx System for Breast Biopsy
- Conditions
- Breast Cancer
- Interventions
- Device: SmartBx
- Registration Number
- NCT03808116
- Lead Sponsor
- UC Care, Ltd.
- Brief Summary
Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of:
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
Examination procedure:
* 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Age 18 years or older
- Planned for breast biopsy procedure.
- Signed informed consent.
o Patient's unwilling to participate.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SmartBx biopsy collection SmartBx * 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
- Primary Outcome Measures
Name Time Method biopsy core yield 1 month biopsy core length will be measured on the needle and on the glass slide and for each core the length on the slide will be computed in reference to the length on the needle
biopsy core length 1 month biopsy core length will be measured on the glass slide
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Haemek medical center
🇮🇱Afula, North Region, Israel