Feasibility of Pantarhei Screener for Cervical Cytology - Full Text View

Sponsors and Collaborators:	Columbia University Pantarhei Devices BV
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00702208

Purpose

The aim of this study is to see whether a new self-sampling device, the Pantarhei Screener (Pantarhei Devices, Zeist, 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 Pantarhei 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: Pantarhei Screener	Phase II

Study Type:	Interventional
Study Design:	Screening, Open Label, Single Group Assignment, Efficacy Study
Official Title:	The Feasibility and Acceptability of Using the Pantarhei Screener for Cervical Cytology Testing Among Low Income Women in New York City

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

Outcome Measure: sensitivity, specificity, kappa compared to gold standard [ Time Frame: cross-sectional ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Outcome: Acceptability of device, complaints from using the device [ Time Frame: cross-sectional ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	September 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Self-sampling device for cervical vaginal lavage

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

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

Contacts

Contact: Heidi E Jones, MPH		hej2103@columbia.edu
Contact: Carolyn L Westhoff, MD		clw3@columbia.edu

Locations

United States, New York
Columbia University Presbyterian Hospital	Recruiting
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Pantarhei Devices BV

Investigators

Principal Investigator:

Carolyn Westhoff, MD

Columbia University

More Information

No publications provided

Responsible Party:	Division of Family Planning & Preventive Services ( Carolyn Westhoff )
Study ID Numbers:	PRD 0801, AAAD1382
Study First Received:	May 30, 2008
Last Updated:	February 2, 2009
ClinicalTrials.gov Identifier:	NCT00702208 History of Changes
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 09, 2009