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OpenTrials
Completed

NCT Number: NCT03808116

Evaluation of the SmartBx System for Breast Biopsy

Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of:

3. Biopsy core length obtained (i.e. collecting all tissue fragments) 4. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haemek medical center

Afula, North Region, 1834111, Israel

About this study

Examination procedure:

  • Biopsy cores will be collected from the breast during US guided biopsy procedure.
  • The number of cores taken will be decided per the physician discretion according to the clinical demand.
  • Additional two biopsy core will be taken the SmartBx cassette. Since the SmartBx cassette holds two biopsies together, two consecutive cores will be collected using the SmartBx.
  • samples will be photographed for measurements in 2 steps during the process:
  • On the needle notch [A].
  • On the glass slide [B].
  • Standard tissue fixation, processing of the samples in paraffin will be performed unchanged per the pathology laboratory protocols.
  • Embedding of the biopsy cores taken with the SmartBx will be embedded using the SmartBx mold and tamper.
  • Standard staining and histology analysis will be preformed to the sectioned samples, unchanged per the pathology protocols.
  • Analysis will be preformed to the histological results, and a comparison between the standard procedures samples to the SmartBx samples will be performed in terms of -
  • Biopsy core length obtained (i.e. collecting all tissue fragments)
  • Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Planned for breast biopsy procedure.
  • Signed informed consent.

Exclusion criteria

o Patient's unwilling to participate.

Treatment and study plan

SmartBx

Device

he SmartBx device is intended for the retention of a biopsy specimen and for preservation of the specimen's in-needle location and orientation.

The SmartBx is used as an aiding tool in biopsy procedures. When operated in conjunction with the standard equipment in a prostate biopsy procedure, the SmartBx may be used for the following:

  • To preserve sample unity, including core fragments in their original location along the needle notch.
  • Avoid sample damaging during sample removal from the needle and the following pathology process.

Primary outcomes

  1. biopsy core length

    Time frame: 1 month

    biopsy core length will be measured on the glass slide

  2. biopsy core yield

    Time frame: 1 month

    biopsy core length will be measured on the needle and on the glass slide and for each core the length on the slide will be computed in reference to the length on the needle

Sponsors and collaborators

Lead sponsor

UC Care, Ltd.

Industry

Registry information

Official study title

Evaluation of the SmartBx System for Breast Biopsy Download While Keeping the Orientation, Unfolding and Unity of the Sample

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 17, 2019
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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