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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

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

Condition or disease Intervention/treatment Phase
Breast Cancer Image Guided Biopsy Device: Smart Biopsy Device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: In Vivo Smart Biopsy Device Protocol In Radiology
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy X-Rays

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)




Primary Outcome Measures :
  1. 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.

  2. Correlation between pathology results and device readings [ Time Frame: 2-3 weeks following biopsy procedure ]
    Correlation between pathology results and device readings

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914911


Locations
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Israel
Meir Medical Center
Kfar Saba, Israel, 4428164
Rabin Medical Center Campus Beilinson
Petah Tikva, Israel, 49100
Sponsors and Collaborators
Dune Medical Devices
Investigators
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Principal Investigator: Noemi Weisenberg Meir Medical Center
Additional Information:
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Responsible Party: Dune Medical Devices
ClinicalTrials.gov Identifier: NCT03914911    
Other Study ID Numbers: CP-10-001
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No