NCT07758140 · Mel Mont Medical
Comparative Self-collection for Cervical Cancer Screening Pivotal Study
(MIA-COMP)
What this study is about
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.
View original scientific description
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).
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.
Primary outcome measures
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.
NPA and PPA
Time frame: Within one week of sample collection.
Concordance between self-collected and physician-collected samples.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Group 1: General Population Group
- Participants are 25 to 65 years of age and willing to provide informed consent.
- Participants have an intact cervix. Group 2: Enriched Population Group
- Participants are 25 to 65 years of age and willing to provide informed consent.
- Participants have an intact cervix.
- 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:
- Impaired decision-making capacity or inability to provide informed consent.
- History of partial or total hysterectomy, including removal of the cervix.
- Cervical tissue alteration or surgery within 5 months prior (conization, LEEP, laser ablation, or cryotherapy).
- Current pregnancy (based on self-reporting).
- Active menstruation at time of specimen collection.
- Vaginal bleeding within 48 hours.
- Have had sex or used tampons, creams, or other vaginal products in the last 48 hours.
- Participation in another clinical study that, in the investigator's opinion, would interfere with the results of this study.
- Any medical reason that, in the investigator's opinion, would disqualify the participant for a routine pelvic exam with cervical sample collection.
Where
- Phoenix, Arizona
- Sherman Oaks, California
- Lake Worth, Florida
- North Miami Beach, Florida
- Boise, Idaho
- Great Falls, Montana
- Raleigh, North Carolina
- Wilmington, North Carolina
- Winston-Salem, North Carolina
- Houston, Texas
- Lynnwood, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 11, 2026 · Source of record for eligibility and locations