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Evaluation of the SmartBx System for Breast Biopsy

NCT03808116 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-11-05

No results posted yet for this study

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)

Conditions

Interventions

DEVICE

SmartBx

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.

Sponsors & Collaborators

  • UC Care, Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-10
Primary Completion
2019-08-05
Completion
2019-09-01

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03808116 on ClinicalTrials.gov