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NCT00702208 · ClinicalTrials.gov registry record · Phase 2
Feasibility of Delphi Screener for Cervical Cytology
A Phase 2 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 198
- Enrollment target
NCT00702208: Completed Phase 2 study, sponsored by Columbia University.
NCT00702208 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 198 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00702208, a Phase 2 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 198 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE Delphi Screener
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2008-09 |
| Est. Completion | 2010-01 |
| Phase | Phase 2 |
What the finished NCT00702208 record still lists
NCT00702208 is an interventional study that assigns participants to a tested intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% higher).
The record links to 0 conditions, and to 1 intervention - of which Delphi Screener is the first listed.
NCT00702208 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00702208 about?
NCT00702208 is a clinical study titled "Feasibility of Delphi Screener for Cervical Cytology". 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...
What is the current status of trial NCT00702208?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 198 participants. The study started on 2008-09. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00702208?
The interventions under investigation include: Delphi Screener (DEVICE).
Who is sponsoring clinical trial NCT00702208?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00702208's enrollment target sits among peer trials
198 349th of 2000 higher than 1,652 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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