In Vivo Smart Biopsy Device Protocol In Radiology

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

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Image Guided Biopsy
• Intervention / Treatment: Device: Smart Biopsy Device

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center Campus Beilinson

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Correlation between pathology results and device readings	Correlation between pathology results and device readings	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.	At the day of the biopsy procedure

Collaborators and Investigators

• Sponsor: Dune Medical Devices
• Investigators: Principal Investigator: Noemi Weisenberg, Meir Medical Center

Publications and helpful links

Helpful Links

• Dune Medical Devices official website

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2019
• Primary Completion (Anticipated): February 28, 2020
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: November 28, 2018
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CP-10-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No