Breast CancerNCT03808116
Evaluation of the SmartBx System for Breast Biopsy
A study testing SmartBx in people with Breast Cancer, run by UC Care, Ltd. at 1 site in Israel.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SmartBx
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Jun 2019to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Planned for breast biopsy procedure.
- Signed informed consent.
Who cannot join
- o Patient's unwilling to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the SmartBx System for Breast Biopsy Download While Keeping the Orientation, Unfolding and Unity of the Sample
Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of:
- Biopsy core length obtained (i.e. collecting all tissue fragments) 4. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)
Read the 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:
- On the needle notch [A].
- 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
- Breast Cancer
- Being tested
- SmartBx
- Keywords
- breast biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartBxDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SmartBx biopsy collection | Experimental | * 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 Receives: Device: SmartBx |
What is being measured
The primary outcome is the main question the study is designed to answer.
biopsy core length
biopsy core length will be measured on the glass slide
Measured: 1 month
biopsy core yield
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start10 Jun 2019
- Primary completion5 Aug 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- UC Care, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808116
- Sponsor's protocol ID
- EMC-0124-18
- Status last verified
- Aug 2019
- First submitted
- 9 Jan 2019
- Last updated
- 5 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the SmartBx System for Breast Biopsy Download While Keeping the Orientation, Unfolding and Unity of the Sample
- ClinicalTrials.gov ID
- NCT03808116
- Acronym / sponsor ID
- EMC-0124-18
- Conditions
- Breast Cancer
- Keywords
- breast biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- UC Care, Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 17 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of:
- 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:
- On the needle notch [A].
- 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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SmartBx biopsy collection | Experimental | Device: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Planned for breast biopsy procedure.
- Signed informed consent.
Key exclusion criteria (1 listed)
- o Patient's unwilling to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartBxhe 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. | Device | SmartBx biopsy collection |
Primary outcome
biopsy core length
Time frame: 1 month
biopsy core length will be measured on the glass slide
biopsy core yield
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartBx in people with Breast Cancer, run by UC Care, Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biopsy core length (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.