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Feasibility of Delphi Screener for Cervical Cytology

NCT00702208 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2014-01-13

Study results available
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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

DEVICE

Delphi Screener

Self-sampling device for cervical vaginal lavage

Sponsors & Collaborators

Principal Investigators

  • Carolyn Westhoff, MD · Columbia University

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00702208 on ClinicalTrials.gov