Breast CancerNCT03914911
In Vivo Smart Biopsy Device Protocol In Radiology
A study testing Smart Biopsy Device in people with Breast Cancer and Image Guided Biopsy, run by Dune Medical Devices at 2 sites in Israel.
Trial summary
This study is designed to demonstrate the feasibility of use of the Smart Biopsy Device in real clinical settings. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Image Guided Biopsy
- What is being tested?
- Smart Biopsy Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesIsrael
- Study dates
- 14 Mar 2019to 31 Mar 2020
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women over 18 years of age
- Undergoing ultrasonic guided core needle biopsy procedure due to abnormality in the breast
- Signed Informed Consent Form
Who cannot join
- Concurrent infectious disease
- Pregnancy or breastfeeding
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
- Implanted devices / Implants in the operated breast
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Meir Medical Center
Kfar Saba, 4428164
Rabin Medical Center Campus Beilinson
Petah Tikva, 49100
About this study
This study is designed to demonstrate the feasibility of use of the Smart Biopsy Device in real clinical settings.
Read the detailed description
This is a single arm, multicenter study. It will be conducted in 3 medical centers, in the breast-imaging unit during ultrasonic guided core needle biopsy procedures performed in women with abnormality in the breast.
The study duration is only during the biopsy procedure, and the follow up period is 2 -3 weeks.
- Conditions
- Breast Cancer, Image Guided Biopsy
- Being tested
- Smart Biopsy Device
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Biopsy DeviceDevice
The radiologist will perform a routine ultrasonic guided biopsy procedure using the smart biopsy system, with the device readings not visible (i.e. the radiologist will be blinded to device readings)
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Experimental | The radiologist will perform a routine ultrasonic guided biopsy procedure using the Smart Biopsy Device, with the device readings not visible (i.e. the radiologist will be blinded to device readings) Receives: Device: Smart Biopsy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs) and serious adverse events (SAEs) Adverse events (AEs)
AEs will be documented during the biopsy procedure and SAEs will be followed up to 3 weeks after the biopsy procedure. Rates of adverse events such as bleeding, hematoma, infection and pain will be compared to adverse events for similar procedures published in the literature and anticipated in the product risk analysis.
Measured: The subjects will be followed for a period of 2 -3 weeks following the biopsy procedure
Correlation between pathology results and device readings
Correlation between pathology results and device readings
Measured: 2-3 weeks following biopsy procedure
Ergonomic Assessment of the Smart Biopsy Device
A questionnaire will be completed by the radiologist and applicable radiology lab staff to assess the ease of device assembly and handling properties. Each of the eight questions will use the same four point rating scale. At the end of the study the average and standard deviation will be calculated for each of the questions.
Measured: At the day of the biopsy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start14 Mar 2019
- Primary completion28 Feb 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dune Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noemi Weisenberg, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914911
- Sponsor's protocol ID
- CP-10-001
- Status last verified
- Jan 2020
- First submitted
- 28 Nov 2018
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Smart Biopsy Device Protocol In Radiology
- ClinicalTrials.gov ID
- NCT03914911
- Acronym / sponsor ID
- CP-10-001
- Conditions
- Breast Cancer, Image Guided Biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Dune Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 16 Apr 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.
This study is designed to demonstrate the feasibility of use of the Smart Biopsy Device in real clinical settings.
Detailed description
This is a single arm, multicenter study. It will be conducted in 3 medical centers, in the breast-imaging unit during ultrasonic guided core needle biopsy procedures performed in women with abnormality in the breast.
The study duration is only during the biopsy procedure, and the follow up period is 2 -3 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Experimental | Device: Smart Biopsy DeviceThe radiologist will perform a routine ultrasonic guided biopsy procedure using the Smart Biopsy Device, with the device readings not visible (i.e. the radiologist will be blinded to device readings) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women over 18 years of age
- Undergoing ultrasonic guided core needle biopsy procedure due to abnormality in the breast
- Signed Informed Consent Form
Key exclusion criteria (4 listed)
- Concurrent infectious disease
- Pregnancy or breastfeeding
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
- Implanted devices / Implants in the operated breast
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 |
|---|---|---|
| Smart Biopsy DeviceThe radiologist will perform a routine ultrasonic guided biopsy procedure using the smart biopsy system, with the device readings not visible (i.e. the radiologist will be blinded to device readings) | Device | Study Arm |
Primary outcome
Incidence of adverse events (AEs) and serious adverse events (SAEs) Adverse events (AEs)
Time frame: The subjects will be followed for a period of 2 -3 weeks following the biopsy procedure
AEs will be documented during the biopsy procedure and SAEs will be followed up to 3 weeks after the biopsy procedure. Rates of adverse events such as bleeding, hematoma, infection and pain will be compared to adverse events for similar procedures published in the literature and anticipated in the product risk analysis.
Correlation between pathology results and device readings
Time frame: 2-3 weeks following biopsy procedure
Correlation between pathology results and device readings
Ergonomic Assessment of the Smart Biopsy Device
Time frame: At the day of the biopsy procedure
A questionnaire will be completed by the radiologist and applicable radiology lab staff to assess the ease of device assembly and handling properties. Each of the eight questions will use the same four point rating scale. At the end of the study the average and standard deviation will be calculated for each of the questions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Dune Medical Devices official websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Noemi Weisenberg principal investigator
Meir Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Biopsy Device in people with Breast Cancer and Image Guided Biopsy, run by Dune Medical Devices at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Incidence of adverse events (AEs) and serious adverse events (SAEs) Adverse events (AEs) (time frame: The subjects will be followed for a period of 2 -3 weeks following the biopsy procedure). The study lists 3 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 31 Jan 2020.