ForeCYTE Breast Aspirator for Sample Collection and Cytological Testing of Nipple Aspirate Fluid
Completed
Conditions studied: Breast Neoplasms
In brief
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%.
Key facts
- Study ID
- NCT02218385
- Run by
- Atossa Therapeutics, Inc.
- People needed
- 52
- Starts
- 2014-08-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2016-10-19
Who can join
Age: 20 and older, up to 75. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Elite Women's Health — New Hyde Park, New York, United States
Full record on ClinicalTrials.gov
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