Clinical trial · Interventional
Comparing Effectiveness of Physician-assisted Versus Self-assisted Pap Smear Collection
A Study to Evaluate the Effectiveness of the Rover Cervex-Brush Device vs. the Personal Pap Smear Device™ for Collection of Cervical Cells for Detecting Cervical Dysplasia or Neoplasia
NCT06229275CI-TRIAL-00092368recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This purpose of this research study is to determine the effectiveness of the Personal Pap Smear Device™ to collect adequate cervical cell samples for cytology examination when compared with the Rover Cervex-Brush (Cervix-Examination Brush).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer Screening | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Comparator: Pap smear collection using the Rovers Cervex-Brush | Device | — | UNRESOLVED |
| Pap smear collection using the Personal Pap Smear (PPS) Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pap smear collection using the Personal Pap Smear (PPS) Device
- description
- The investigational device, trade named the Personal Pap Smear™ (PPS) developed by GyneConcepts of Atlanta, Georgia. It arrives completely assembled, and ready-for-use, in a sealed plastic bag. The PPS device is a multi-component assembly designed for the collection of exfoliated cervical epithelial cells. Its four major components are the (1) Tube Body, (2) U-Ring and attached Aligning Spoon, (3) Ball Handle, (with permanently anchored bristle Collection Brush), and (4) Safety Cover.
- interventionNames
- Device: Pap smear collection using the Personal Pap Smear (PPS) Device
- type
- ACTIVE_COMPARATOR
- label
- Pap smear collection using the Rovers Cervex-Brush
- description
- The Predicate device utilized in this study is the Cervix-Examination Brush, manufactured by Rover (Manufacturers Code: 9443). The Cervex-Brush (CervixExamination Brush) is made of polyethylene and has a total length of 20 centimeters. The top portion uses a soft flexible brush to obtain cell samples. The brush consists of 57 semi-circular plastic bristles of various lengths. The shape is such that the top edges of the brush follow the contours of the cervix. The longer middle bristles reach deep into the endocervical canal- 'Os'. The shorter bristles touch both the ectocervical area and transformation zone at the same time. This device is packaged with identical standards used for packaging commercial tampons.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Adult women, aged 21-65 years old. * Do not have any medical or psychiatric condition affecting the ability to give voluntary informed consent. * Be able to read and understand English Exclusion Criteria: * Participants currently on menses * Inability to provide Informed Consent * Previous total hysterectomy * History of radiation treatment for cervical cancer * Pregnancy * Medical condition that interferes with conduct of study, in investigator's opinion * Evidence of active cervical infection requiring treatment * Known bleeding diathesis
References
Publications (0)
Data not yet available
No reference posted for this study.