Status:
COMPLETED
ForeCYTE Breast Aspirator for Sample Collection and Cytological Testing of Nipple Aspirate Fluid
Lead Sponsor:
Atossa Therapeutics, Inc.
Collaborating Sponsors:
Quest Diagnostics-Nichols Insitute
National Reference Laboratory for Breast Health
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
20-75 years
Brief 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 Aspirat...
Detailed Description
A) NAF Collection at physician's office: The Principle Investigator identified and qualified the study subjects. He and the assigned study coordinator from his clinic completed all entries in the Stud...
Eligibility Criteria
Inclusion
- Healthy, female, age 20-75 years, from whom bi-lateral specimens can be obtained.
- Any woman for whom NAF cytology testing is considered to be beneficial by her physician.
- Non-lactating and non-pregnant (as documented by date of Last Menstrual Period or post-menopausal).
- Good general health as determined by medical history, breast disease/cancer history, and clinical breast exam.
- Willing to give informed consent and follow study procedures as directed.
Exclusion
- Medical condition/psychiatric conditions making subjects a poor candidate for study, as determined by the Principal Investigator.
- Pregnancy or suspicion of pregnancy.
- Open cutaneous wounds or atopic dermatitis in the area of the nipple-areolar complex.
- No or inverted nipple on the breast unfit for fluid collection, or significant prior surgery in the area of the nipple-areolar complex.
- Participation in an investigational drug or device study less than 30 days prior to enrollment in this study.
- Pregnancy, childbirth, or lactation less than 90 days prior to enrollment in this study.
- Acute illness, including taking antibiotics, analgesics, antipyretics and/or cold medications less than 7 days prior to enrollment in this study.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT02218385
Start Date
August 1 2014
End Date
August 1 2014
Last Update
October 19 2016
Active Locations (1)
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1
Elite Women's Health
New Hyde Park, New York, United States, 11042