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Clinical Trials in the USA / NCT07758140
Recruiting Not applicable

Comparative Self-collection for Cervical Cancer Screening Pivotal Study

NCT07758140 · tracked via the Priya Life Science USA tracker
Sponsor
Mel Mont Medical
Phase
Not applicable
Started
2026-07-09
Last updated
2026-08-11

Condition(s) studied

HPVHPV - Anogenital Human Papilloma Virus Infection

Investigational drug(s) / intervention(s)

Mia by XytoTestRovers Cervex-Brush

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

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

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).

Eligibility

Sex
FEMALE
Min age
25 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: Group 1: General Population Group 1. Participants are 25 to 65 years of age and willing to provide informed consent. 2. Participants have an intact cervix. Group 2: 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. Exclusion Criteria: Apply to all groups: 1. Impaired decision-making capacity or inability to provide informed consent. 2. History of partial or total hysterectomy, including removal of the cervix. 3. Cervical tissue alteration or surgery within 5 months prior (conization, LEEP, laser ablation, or cryotherapy). 4. Current pregnancy (based on self-reporting). 5. Active menstruation at time of specimen collection. 6. Vaginal bleeding within 48 hours. 7. Have had sex or used tampons, creams, or other vaginal products in the last 48 hours. 8. Participation in another clinical study that, in the investigator's opinion, would interfere with the results of this study. 9. Any medical reason that, in the investigator's opinion, would disqualify the participant for a routine pelvic exam with cervical sample collection.

Primary outcome measure(s)

  • Rate of SAEs — Between 6 and 14 days.
    Rate of self-collection using Mia as compared to rate of SAEs from clinician-collection.
  • NPA and PPA — Within one week of sample collection.
    Concordance between self-collected and physician-collected samples.

Trial sites (11)

FacilityCityRegionStatus
ASR Arizona CGA Phoenix Arizona Recruiting
Integrated Clinical Research Sherman Oaks California Recruiting
Altus Clinical Research Lake Worth Florida Recruiting
Zenacare Research North Miami Beach Florida Recruiting
ASR Idaho CGI Boise Idaho Recruiting
Boeson Research - Great Falls Great Falls Montana Recruiting
Unified Women's Clinical Research Raleigh North Carolina Recruiting
Innovo-Wilmington Health Wilmington North Carolina Recruiting
Lyndhurst Clinical Research (Unified) Winston-Salem North Carolina Recruiting
El Centro de Corazon Houston Texas Recruiting
National Eagle Research Lynnwood Washington Recruiting

Other trials for the same condition

SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07758140 on ClinicalTrials.gov ↗ ← All trials in the USA