Breast Cancer, Image Guided Biopsy
Conditions
Brief summary
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.
Interventions
DEVICESmart Biopsy 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)
Sponsors
Dune Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women over 18 years of age * Undergoing ultrasonic guided core needle biopsy procedure due to abnormality in the breast * Signed Informed Consent Form
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs) Adverse events (AEs) | 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 | 2-3 weeks following biopsy procedure | Correlation between pathology results and device readings |
| Ergonomic Assessment of the Smart Biopsy Device | 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. |
Countries
Israel
Outcome results
None listed