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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
Sponsor:
Information provided by (Responsible Party):
Dune Medical Devices

Tracking Information
First Submitted Date  ICMJE November 28, 2018
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date January 31, 2020
Actual Study Start Date  ICMJE March 14, 2019
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2019)
  • Safety of the Smart Biopsy [ Time Frame: The subjects will be followed for a period of 2 -3 weeks following the biopsy procedure ]
    Adverse events (AEs) will be documented during the biopsy procedure and serious adverse events (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 of the Smart Biopsy [ Time Frame: At the day of the biopsy procedure ]
    Ergonomic questionnaire will be provided to the radiologist and applicable radiology lab staff to provide feedback on device use and handling.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE In Vivo Smart Biopsy Device Protocol In Radiology
Official Title  ICMJE In Vivo Smart Biopsy Device Protocol In Radiology
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Breast Cancer
  • Image Guided Biopsy
Intervention  ICMJE 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)
Study Arms  ICMJE 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)
Intervention: Device: Smart Biopsy Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 30, 2020)
41
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2019)
100
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03914911
Other Study ID Numbers  ICMJE CP-10-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dune Medical Devices
Study Sponsor  ICMJE Dune Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Noemi Weisenberg Meir Medical Center
PRS Account Dune Medical Devices
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP