In Vivo Smart Biopsy Device Protocol In Radiology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-14

Study Completion Date

2020-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Breast Cancer Image Guided Biopsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Smart Biopsy Device

Intervention Type 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)

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes