Clinical trial · Interventional
Feasibility of Delphi Screener for Cervical Cytology
The Feasibility and Acceptability of Using the Delphi Screener for Cervical Cytology Testing Among Low Income Women in New York City
- 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 aim of this study is to see whether a new self-sampling device, the Delphi Screener (Delphi Devices, Scherpenzeel, Netherlands), can be used for cervical cancer screening. The results using the new device will be compared to results using the current gold standard. The gold standard is clinician-collected endo-cervical and ecto-cervical specimens (often referred to as a 'Pap smear'). Additionally, women will be asked about the acceptability of using the device and how easy it is to understand the user instructions. The Delphi Screener is a sterile, plastic, syringe-like device containing buffered saline which allows a woman to collect her own vaginal lavage (to 'self-squirt'). The hypothesis is that the device may work well for cervical cytology and will be acceptable to the women in the study.
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 |
|---|---|---|---|
| Cervical Neoplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Delphi Screener | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single arm study
- description
- Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk human papillomavirus testing for sub-sample)
- interventionNames
- Device: Delphi Screener
Primary outcomes (2)
- measure
- Sensitivity and Specificity
- timeFrame
- 1-3 months between 2 specimen collections
- description
- We calculated sensitivity of self-collected lavage with cytology to detect histologically confirmed high grade lesions (cervical intraepithelial neoplasia, CIN, 2+); specificity for histology-negative (CIN 1 or lower), paired cytology negative, or a third cytology negative; and kappa for paired results. The cytology specimens were collected 1-3 months apart and women with abnormal results for cytology were followed through January 2010 for final histology endpoints.
- measure
- Kappa Coefficient
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Valid Pap smear in last 1-3 months obtained at participating clinic * 18 years or older * Self-report being able to read in English and/or Spanish * Willing to sign informed consent Exclusion Criteria: * Used vaginal product (douche, spermicide, antifungal) in last 48 hours * Last menses started ≤ 4 days prior to enrollment visit * No uterus / history of hysterectomy * Self-report currently pregnant * Self-report currently breastfeeding
References
Publications (1)
- DERIVEDJones HE, Mansukhani MM, Tong GX, Westhoff CL. Validity and reliability of using a self-lavaging device for cytology and HPV testing for cervical cancer screening: findings from a pilot study. PLoS One. 2013 Dec 20;8(12):e82115. doi: 10.1371/journal.pone.0082115. eCollection 2013. PMID 24376516