CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 198 enrolled
Drug / intervention
Delphi Screenerdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00702208
NCT00702208Phase 2Completed

The Feasibility and Acceptability of Using the Delphi Screener for Cervical Cytology Testing Among Low Income Women in New York City

Columbia University·interventional·Posted Jun 20, 2008·Updated Jan 13, 2014

In Brief

A Phase 2 clinical trial evaluating Delphi Screener for Cervical Neoplasia. Completed, enrolled 198 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsDelphi Devices BV

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 20, 2008
Enrollment StartSep 1, 2008
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.0 years ago

Interventions

Delphi Screenerdevice

Self-sampling device for cervical vaginal lavage