Clinical trial · Observational
ForeCYTE Breast Aspirator for Sample Collection and Cytological Testing of Nipple Aspirate Fluid
A Single-arm, Multi-laboratory Clinical Trial of the ForeCYTE Breast Aspirator for Sample Collection, Processing and Cytological Testing of Nipple Aspirate Fluid
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ForeCYTE Breast Aspirator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ForeCYTE Breast Aspirator
- description
- ForeCYTE Breast Aspirator used for bilateral collection of Nipple Aspirate Fluid (NAF) for cytologic testing
- interventionNames
- Device: ForeCYTE Breast Aspirator
Primary outcomes (1)
- measure
- Specimen Acceptance Rate
- timeFrame
- Within 2 weeks after specimen collection
- description
- 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.
Secondary outcomes (1)
- measure
- Safety / Investigational Device Adverse Effects
- timeFrame
- Day of specimen collection
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Healthy, female, age 20-75 years, from whom bi-lateral specimens can be obtained. 2. Any woman for whom NAF cytology testing is considered to be beneficial by her physician. 3. Non-lactating and non-pregnant (as documented by date of Last Menstrual Period or post-menopausal). 4. Good general health as determined by medical history, breast disease/cancer history, and clinical breast exam. 5. Willing to give informed consent and follow study procedures as directed. Exclusion Criteria: 1. Medical condition/psychiatric conditions making subjects a poor candidate for study, as determined by the Principal Investigator. 2. Pregnancy or suspicion of pregnancy. 3. Open cutaneous wounds or atopic dermatitis in the area of the nipple-areolar complex. 4. No or inverted nipple on the breast unfit for fluid collection, or significant prior surgery in the area of the nipple-areolar complex. 5. Participation in an investigational drug or device study less than 30 days prior to enrollment in this study. 6. Pregnancy, childbirth, or lactation less than 90 days prior to enrollment in this study. 7. Acute illness, including taking antibiotics, analgesics, antipyretics and/or cold medications less than 7 days prior to enrollment in this study.
References
Publications (0)
Data not yet available