Feasibility of Delphi Screener for Cervical Cytology

Completed · Phase 2

Conditions studied: Cervical Neoplasia

In brief

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.

Key facts

Study ID

NCT00702208

Run by

Columbia University

People needed

198

Starts

2008-09-01

Expected to finish

2010-01-01

Last updated by the study team

2014-01-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Columbia University Presbyterian Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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