Feasibility of Delphi Screener for Cervical Cytology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00702208
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : January 13, 2014
Last Update Posted : January 13, 2014
Delphi Devices BV
Information provided by (Responsible Party):
Carolyn L. Westhoff, Columbia University

Brief 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.

Condition or disease Intervention/treatment Phase
Cervical Neoplasia Device: Delphi Screener Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Feasibility and Acceptability of Using the Delphi Screener for Cervical Cytology Testing Among Low Income Women in New York City
Study Start Date : September 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
Single arm study
Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk human papillomavirus testing for sub-sample)
Device: Delphi Screener
Self-sampling device for cervical vaginal lavage
Other Names:
  • Pantarhei Screener
  • Mermaid

Primary Outcome Measures :
  1. Sensitivity and Specificity [ Time Frame: 1-3 months between 2 specimen collections ]

    We calculated sensitivity of self-collected lavage with cytology to detect histologically confirmed high grade lesions (cervical intraepithelial neoplasia, CIN, 2+); specificity for histology-negative (CIN 1 or lower), paired cytology negative, or a third cytology negative; and kappa for paired results.

    The cytology specimens were collected 1-3 months apart and women with abnormal results for cytology were followed through January 2010 for final histology endpoints.

  2. Kappa Coefficient [ Time Frame: 1-3 months between 2 specimen collections ]
    Kappa comparing clinician-collected cytology result to self-lavage cytology result

Secondary Outcome Measures :
  1. Outcome: Acceptability of Device [ Time Frame: cross-sectional - asked at time of Screener use ]
    On a visual analog scale from 0-10 cm, preference for clinician-collected specimen (0) vs. self-lavage specimen (10) for future cervical cancer screening

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00702208

United States, New York
Columbia University Presbyterian Hospital
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Delphi Devices BV
Principal Investigator: Carolyn Westhoff, MD Columbia University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Carolyn L. Westhoff, Professor of Obstetrics and Gynecology, Population and Family Health and Epidemiology at the New York-Presbyterian Hospital at the Columbia University Medical Center, Columbia University Identifier: NCT00702208     History of Changes
Other Study ID Numbers: AAAD1382
First Posted: June 20, 2008    Key Record Dates
Results First Posted: January 13, 2014
Last Update Posted: January 13, 2014
Last Verified: July 2013

Keywords provided by Carolyn L. Westhoff, Columbia University:
cervical cytology
Pap smear