In Vivo Smart Biopsy Device Protocol In Radiology

Breast Cancer Clinical Trial

Official title:

In Vivo Smart Biopsy Device Protocol In Radiology

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03914911
• Other study ID #: CP-10-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 14, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: January 2020
• Source: Dune Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to demonstrate the feasibility of use of the Smart Biopsy Device in real clinical settings.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Image Guided Biopsy

Intervention

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)

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center Campus Beilinson	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Dune Medical Devices

Country where clinical trial is conducted

Israel, 

Outcome

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

External Links

•   Dune Medical Devices official website