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A Trial of the ForeCYTE Breast Aspirator for Cytological Testing of Nipple Aspirate Fluid in Women 30-55 Years Old

NCT02539615 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-01-25

No results posted yet for this study

Summary

The purpose of this study is to measure the performance of the ForeCYTE Breast Aspirator for the collection and processing of Nipple Aspirate Fluid (NAF) specimens for cytology. Including collecting, processing and shipping samples, training staff, processing samples, sample interpretation and accurate and timely reporting in a manner resembling routine clinical use. The study will include a subset of patients who are known carriers of a BRCA germline mutation. NAF from this subset will be submitted for molecular testing in addition to cytology.

Conditions

  • Breast Cancer, Preneoplastic Conditions, BRCA

Interventions

DEVICE

ForeCYTE Breast Aspirator

Sponsors & Collaborators

  • Atossa Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jelle Kylstra · Atossa Therapeutics, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2015-12-31
Completion
2016-03-31

Countries

  • Israel

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 NCT02539615 on ClinicalTrials.gov