NCT00702208

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cervical Neoplasia

Interventions

Type	Name	Description
DEVICE	Delphi Screener	Self-sampling device for cervical vaginal lavage

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2008-06-20
• Last updated: 2014-01-13
• Results posted: 2014-01-13

Locations

1 site across 1 country: United States