Feasibility of Delphi Screener for Cervical Cytology

Columbia University

Status and phase: Completed; Phase 2

Conditions: Cervical Neoplasia

Treatments: Device: Delphi Screener

Study type: Interventional

Funder types: Other

Identifiers

NCT00702208

AAAD1382

Details and patient eligibility

About

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.

Enrollment: 198 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

198 participants in 1 patient group

Single arm study

Other group

Description:

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

Treatment:

Device: Delphi Screener