In Vivo Smart Biopsy Device Protocol In Radiology

Dune Medical Devices41 enrolled

Overview

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

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Breast Cancer Image Guided Biopsy

Interventions

Smart Biopsy DeviceDEVICE

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)

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Meir Medical Center

Kfar Saba, Israel

Rabin Medical Center Campus Beilinson

Petah Tikva, Israel

Outcomes

Primary Outcomes

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.

Time frame: The subjects will be followed for a period of 2 -3 weeks following the biopsy procedure

Correlation between pathology results and device readings

Time frame: 2-3 weeks following biopsy procedure

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.

Time frame: At the day of the biopsy procedure

Data from ClinicalTrials.gov

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