Feasibility of Delphi Screener for Cervical Cytology

This study has been completed.
Sponsor:
Collaborator:
Delphi Devices BV
Information provided by (Responsible Party):
Carolyn L. Westhoff, Columbia University
ClinicalTrials.gov Identifier:
NCT00702208
First received: May 30, 2008
Last updated: December 12, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Cervical Neoplasia
Device: Delphi Screener
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Sensitivity and Specificity [ Time Frame: 1-3 months between 2 specimen collections ] [ Designated as safety issue: No ]

    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.


  • Kappa Coefficient [ Time Frame: 1-3 months between 2 specimen collections ] [ Designated as safety issue: No ]
    Kappa comparing clinician-collected cytology result to self-lavage cytology result


Secondary Outcome Measures:
  • Outcome: Acceptability of Device [ Time Frame: cross-sectional - asked at time of Screener use ] [ Designated as safety issue: Yes ]
    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


Enrollment: 198
Study Start Date: September 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702208

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

No publications provided by Columbia University

Additional publications automatically indexed to this study by ClinicalTrials.gov 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
ClinicalTrials.gov Identifier: NCT00702208     History of Changes
Other Study ID Numbers: AAAD1382
Study First Received: May 30, 2008
Results First Received: July 29, 2013
Last Updated: December 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
cervical cytology
Pap smear
self-sampling
abnormal
normal

ClinicalTrials.gov processed this record on September 18, 2014