Cervical Neoplasia Clinical Trial
Official title:
The Feasibility and Acceptability of Using the Delphi Screener for Cervical Cytology Testing Among Low Income Women in New York City
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.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
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