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NCT02218385 · ClinicalTrials.gov registry record
ForeCYTE Breast Aspirator for Sample Collection and Cytological Testing of Nipple Aspirate Fluid
A clinical trial, sponsored by Atossa Therapeutics.
- Completed
- Registry status
- 52
- Enrollment target
NCT02218385: Completed study, sponsored by Atossa Therapeutics.
NCT02218385 is a clinical trial that has completed, run by Atossa Therapeutics. The registered enrollment target is 52 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02218385 has completed, sponsored by Atossa Therapeutics.
- COMPLETED
- Registry status
- 52 participants
- Enrollment target
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%.
Primary Outcome
A specimen collected, fixated, shipped and received by the reference lab per specification, and rated by the receiving lab as acceptable for cytological testing and interpretation, is deemed acceptable.
Interventions
- DEVICE ForeCYTE Breast Aspirator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2014-08 |
| Est. Completion | 2014-08 |
What the finished NCT02218385 record still lists
NCT02218385 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 52 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which ForeCYTE Breast Aspirator is the first listed.
NCT02218385 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02218385 about?
NCT02218385 is a clinical study titled "ForeCYTE Breast Aspirator for Sample Collection and Cytological Testing of Nipple Aspirate Fluid". 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 st...
What is the current status of trial NCT02218385?
This trial is currently completed. The enrollment target is 52 participants. The study started on 2014-08. Estimated completion is 2014-08.
What interventions are being tested in trial NCT02218385?
The interventions under investigation include: ForeCYTE Breast Aspirator (DEVICE).
Who is sponsoring clinical trial NCT02218385?
This trial is sponsored by Atossa Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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