In Vivo Smart Biopsy Device Protocol In Radiology
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03914911|
Recruitment Status : Active, not recruiting
First Posted : April 16, 2019
Last Update Posted : January 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Image Guided Biopsy||Device: Smart Biopsy Device||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||In Vivo Smart Biopsy Device Protocol In Radiology|
|Actual Study Start Date :||March 14, 2019|
|Estimated Primary Completion Date :||February 28, 2020|
|Estimated Study Completion Date :||March 31, 2020|
Experimental: Study Arm
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)
Device: Smart 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)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914911
|Meir Medical Center|
|Kfar Saba, Israel, 4428164|
|Rabin Medical Center Campus Beilinson|
|Petah Tikva, Israel, 49100|
|Principal Investigator:||Noemi Weisenberg||Meir Medical Center|