Feasibility of Delphi Screener for Cervical Cytology

NCT ID: NCT00702208

Last Updated: 2014-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-01-31

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.

Conditions

Cervical Neoplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Single arm study

Paired laboratory results for clinician-collected and Screener collected specimens for cytology (and high-risk human papillomavirus testing for sub-sample)

Group Type: OTHER

Delphi Screener

Intervention Type: DEVICE

Self-sampling device for cervical vaginal lavage

Interventions

Delphi Screener

Self-sampling device for cervical vaginal lavage

Intervention Type: DEVICE

Other Intervention Names

Pantarhei Screener; Mermaid

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Delphi Devices BV

UNKNOWN

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolyn Westhoff, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Presbyterian Hospital

New York, New York, United States

Countries

United States

References

Jones HE, Mansukhani MM, Tong GX, Westhoff CL. Validity and reliability of using a self-lavaging device for cytology and HPV testing for cervical cancer screening: findings from a pilot study. PLoS One. 2013 Dec 20;8(12):e82115. doi: 10.1371/journal.pone.0082115. eCollection 2013.

Reference Type: DERIVED

PMID: 24376516 (View on PubMed)

Other Identifiers

AAAD1382

Identifier Type: -

Identifier Source: org_study_id