Study Comparing Self-Collection Using the Mia Device to Doctor-Collected Samples for Cervical Cancer Screening in Women Aged 25 to 65

What this Trial Is About

Researchers are evaluating the Mia by XytoTest self-collection device for its ability to help women aged 25 to 65 perform vaginal sample collection for high-risk HPV hrHPV screening. The study aims to compare the self-collected samples with clinician-collected cervical samples using the cobas HPV Test to determine diagnostic agreement. The trial also seeks to confirm the devices safety and ensure that a diverse group of users can use it effectively as directed. Participants will use the Mia device, a single-use, sterile, disposable tool designed for self-collection of vaginal specimens. These self-collected samples will be compared with samples taken by clinicians using the Rovers Cervex-Brush. The study involves two groups a general population group and an enriched population group with prior hrHPV diagnosis or abnormal cervical cytology. Residual samples may be tested further for other assays related to cervical health. During the study, participants will provide vaginal and cervical samples for hrHPV detection, with safety monitored between 6 and 14 days after sample collection. Researchers will measure the rate of serious adverse events and compare the agreement between self-collected and clinician-collected samples. Participation includes following device instructions, sample collection, and attending visits within one week of collection. The trial is expected to complete by September 2026.

Comparative Self-collection for Cervical Cancer Screening Pivotal Study