Phase 2
N=198
Feasibility of Delphi Screener for Cervical Cytology
Cervical Neoplasia
Bottom Line
View on ClinicalTrials.gov: NCT00702208 ↗Enrolled (actual)
198
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Sensitivity and Specificity — 0.86; 0.80 % of participants correctly diagnosed
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Delphi Screener (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Columbia University
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity |
0.86; 0.80 | — |
| PRIMARY Kappa Coefficient |
0.36 | — |
| SECONDARY Outcome: Acceptability of Device |
9.6 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00702208). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.