NCT07758140 Comparative Self-collection for Cervical Cancer Screening Pivotal Study
| NCT ID | NCT07758140 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mel Mont Medical |
| Condition | HPV |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2026-07-09 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 260 participants in total. It began in 2026-07-09 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07758140 clinical trial?
This trial is open to female participants only, aged 25 Years or older, up to 65 Years, studying HPV. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07758140 currently recruiting?
Yes, NCT07758140 is actively recruiting participants. Contact the research team at l.montes@xytotest.com for enrollment information.
Where is the NCT07758140 trial being conducted?
This trial is being conducted at Phoenix, United States, Sherman Oaks, United States, Lake Worth, United States, North Miami Beach, United States and 7 additional locations.
Who is sponsoring the NCT07758140 clinical trial?
NCT07758140 is sponsored by Mel Mont Medical. The trial plans to enroll 260 participants.