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This study is designed to demonstrate the feasibility of use of the Smart Biopsy Device in real clinical settings.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart Biopsy Device | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | At the day of the biopsy procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noemi Weisenberg | Meir Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical Center | Kfar Saba | 4428164 | Israel | |||
| Rabin Medical Center Campus Beilinson |
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| Label | URL |
|---|---|
| Dune Medical Devices official website | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Petah Tikva |
| 49100 |
| Israel |
| D017437 |
| Skin and Connective Tissue Diseases |