Breast Cancer Clinical Trial
Official title:
In Vivo Smart Biopsy Device Protocol In Radiology
Verified date | January 2020 |
Source | Dune Medical Devices |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed to demonstrate the feasibility of use of the Smart Biopsy Device in real clinical settings.
Status | Active, not recruiting |
Enrollment | 41 |
Est. completion date | March 31, 2020 |
Est. primary completion date | February 28, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Israel | Meir Medical Center | Kfar Saba | |
Israel | Rabin Medical Center Campus Beilinson | Petah Tikva |
Lead Sponsor | Collaborator |
---|---|
Dune Medical Devices |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Correlation between pathology results and device readings | Correlation between pathology results and device readings | 2-3 weeks following biopsy procedure | |
Primary | 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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