Comparative Self-collection for Cervical Cancer Screening Pivotal Study (MIA-COMP)

August 6, 2026 updated by: Mel Mont Medical

MIA-COMP Pivotal Study: COMParative Self-Collection for Cervical Cancer Screening

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this pivotal study is to generate the clinical evidence necessary to support FDA marketing authorization for the Mia device. Specifically, the study will evaluate the diagnostic agreement of Mia-collected self-samples against the standard of care clinician-collected method for primary hrHPV detection, confirm device safety, demonstrate that end users across a diverse population can use the device safely and effectively as directed.

Study Type

Interventional

Enrollment (Estimated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Recruiting
        • ASR Arizona CGA
        • Contact:
    • California
      • Sherman Oaks, California, United States, 91403
        • Recruiting
        • Integrated Clinical Research
        • Contact:
    • Florida
      • Lake Worth, Florida, United States, 33461
        • Recruiting
        • Altus Clinical Research
        • Contact:
      • North Miami Beach, Florida, United States, 33169
        • Recruiting
        • Zenacare Research
        • Contact:
    • Idaho
      • Boise, Idaho, United States, 83702
    • Montana
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Boeson Research - Great Falls
        • Contact:
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
      • Wilmington, North Carolina, United States, 28401
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Lyndhurst Clinical Research (Unified)
        • Contact:
          • Amie Butler
          • Phone Number: 336-765-9350
    • Texas
      • Houston, Texas, United States, 77012
    • Washington
      • Lynnwood, Washington, United States, 98036

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of SAEs
Time Frame: Between 6 and 14 days.
Rate of self-collection using Mia as compared to rate of SAEs from clinician-collection.
Between 6 and 14 days.
NPA and PPA
Time Frame: Within one week of sample collection.
Concordance between self-collected and physician-collected samples.
Within one week of sample collection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mel Mont Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 6, 2026

First Submitted That Met QC Criteria

August 6, 2026

First Posted (Actual)

August 11, 2026

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 6, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CLIN-MIA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe