In Vivo Smart Biopsy Device Protocol In Radiology

Not Applicable

• Conditions: Breast Cancer; Image Guided Biopsy
• Interventions: Device: Smart Biopsy Device

• Registration Number: NCT03914911
• Lead Sponsor: Dune Medical Devices

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.

Study Timeline

• Study First Submitted: 2018-11-28
• Study Start: 2019-03-14
• Study First Submitted QC: 2019-04-11
• Study First Posted: 2019-04-16
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-30
• Last Update Posted: 2020-01-31
• Primary Completion: 2020-02-28
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Arm	Smart Biopsy Device	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)

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (2)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel

Rabin Medical Center Campus Beilinson; 🇮🇱 Petah Tikva, Israel