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ForeCYTE Breast Aspirator for Sample Collection and Cytological Testing of Nipple Aspirate Fluid

NCT02218385 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 52

Last updated 2016-10-19

No results posted yet for this study

Summary

The purpose of this study is to measure the performance characteristics for the collection, fixation and transportation of clinical nipple aspirate fluid (NAF) specimens of the ForeCYTE Breast Aspirator across 3 independent labs and the National Reference Laboratory for Breast Health (NRLBH). The study hypothesis is that each lab will have a specimen acceptability rate of at least 90%. If it is assumed that the true level of acceptability testing is approximately 96%, then the lower bound of a one-sided 95% confidence interval is expected to be at least 90%.

Conditions

  • Breast Neoplasms

Interventions

DEVICE

ForeCYTE Breast Aspirator

ForeCYTE Breast Aspirator used for bilateral collection of Nipple Aspirate Fluid (NAF) for cytologic testing

Sponsors & Collaborators

  • Quest Diagnostics-Nichols Insitute

    collaborator INDUSTRY

  • National Reference Laboratory for Breast Health

    collaborator UNKNOWN

  • Sound Pathology Associates

    collaborator UNKNOWN

  • Puget Sound Institute of Pathology

    collaborator OTHER

  • Atossa Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jonathan D. Herman, MD, FACOG · Elite Women's Health

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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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 NCT02218385 on ClinicalTrials.gov