Evaluating the Personal Pap Smear Device Versus the Rover Cervex-Brush for Collecting Cervical Cells to Detect Cervical Abnormalities

What this Trial Is About

This research aims to compare the effectiveness of two devices in collecting cervical cell samples for cytology examination to detect cervical dysplasia or neoplasia. The study focuses on adult women aged 21 to 65 undergoing cervical cancer screening, evaluating how well the Personal Pap Smear Device collects samples compared to the Rover Cervex-Brush Cervix-Examination Brush. The goal is to determine which device provides adequate samples following the Bethesda Guidelines 2014. The study includes two groups one using the Personal Pap Smear Device, a multi-component tool designed for cervical cell collection, and the other using the Rover Cervex-Brush, a flexible brush with bristles shaped to follow the cervix contour. Both devices are used during pap smear collection to gather exfoliated cervical epithelial cells. The Personal Pap Smear Device arrives ready to use, and the Rover Cervex-Brush is a commercially packaged comparator device. Participants will undergo pap smear collection with one of the devices, and the collected samples will be analyzed for adequacy and cell types. Researchers will compare samples from both devices to measure effectiveness. The study involves random assignment to either device group, with no masking. Participants are monitored for safety and sample quality, with data collected at baseline. The study lasts for the necessary duration to complete these assessments and ensure proper monitoring.

Comparing Effectiveness of Physician-assisted Versus Self-assisted Pap Smear Collection