Comparative Self-collection for Cervical Cancer Screening Pivotal Study

Conditions

• HPV
• HPV - Anogenital Human Papilloma Virus Infection

Eligibility Criteria

Sex

FEMALE

Age

25 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Mia by XytoTest — DIAGNOSTIC_TEST
  Mia by XytoTest is a single-use, sterile, disposable device intended for self-collection of vaginal specimens
• Rovers Cervex-Brush — DIAGNOSTIC_TEST
  Rovers Cervex-Brush is for physician collection of vaginal specimens.

Study Details

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).

Key Dates

First listed

Aug 11, 2026

Start date

Jul 9, 2026

Status verified

Aug 2026

Primary completion

Aug 31, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

260 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• Active Comparator: General Population Group
  1. Participants are 25 to 65 years of age and willing to provide informed consent. 2. Participants have an intact cervix.
• Active Comparator: Enriched Population Group
  1. Participants are 25 to 65 years of age and willing to provide informed consent. 2. Participants have an intact cervix. 3. One or more of: prior diagnosis of hrHPV within previous 6 months; abnormal cervical Pap cytology result of HSIL or higher (HSIL, AIS, or invasive carcinoma per the Bethesda 2014 system) within previous 6 months; and/or presenting for colposcopy/LEEP/excisional intervention.

Primary Outcome Measure

Rate of SAEs [ Time Frame: Between 6 and 14 days. ]

Central Contacts

• Liliana Montes
  305 335 6162
  [email protected]
• Rowena Schokman
  301-641-3215
  [email protected]

Locations (11)

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