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Comparative Self-collection for Cervical Cancer Screening Pivotal Study

NCT07758140 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-08-11

No results posted yet for this study

Summary

To evaluate whether individuals drawn from the intended use population can successfully interpret and follow the IFU for the Mia by XytoTest self-collection device and perform a vaginal sample collection yielding sufficient cellular material for primary hrHPV screening.

To assess the clinical performance of Mia self-collected vaginal specimens by evaluating agreement with paired clinician-collected cervical specimens for the detection of high-risk HPV, when both specimen types are analyzed using the cobas HPV Test (Roche Molecular Systems). Residual samples may be used to determine adequacy for additional assays that require vaginal and/or cervical specimens (such as mRNA E6 and E7 Biomarker Test, dual stain cytology).

Conditions

  • HPV
  • HPV - Anogenital Human Papilloma Virus Infection

Interventions

DIAGNOSTIC_TEST

Mia by XytoTest

Mia by XytoTest is a single-use, sterile, disposable device intended for self-collection of vaginal specimens

DIAGNOSTIC_TEST

Rovers Cervex-Brush

Rovers Cervex-Brush is for physician collection of vaginal specimens.

Sponsors & Collaborators

  • Mel Mont Medical

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-09
Primary Completion
2026-08-31
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07758140 on ClinicalTrials.gov