NCT03808116

Brief Summary

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 17, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

June 10, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2019

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

November 5, 2020

Status Verified

August 1, 2019

Enrollment Period

2 months

First QC Date

January 9, 2019

Last Update Submit

November 3, 2020

Conditions

Breast Cancer

Keywords

breast biopsy

Outcome Measures

Primary Outcomes (2)

  • biopsy core length

    biopsy core length will be measured on the glass slide

    1 month

  • biopsy core yield

    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

    1 month

Study Arms (1)

SmartBx biopsy collection

EXPERIMENTAL

* 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

Device: SmartBx

Interventions

SmartBxDEVICE

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.

SmartBx biopsy collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • o Patient's unwilling to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haemek medical center

Afula, North Region, 1834111, Israel

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 17, 2019

Study Start

June 10, 2019

Primary Completion

August 5, 2019

Study Completion

September 1, 2019

Last Updated

November 5, 2020

Record last verified: 2019-08

Locations

IL(1)