Self-collection for Cervical Cancer Screening
Comparative Self-collection for Cervical Cancer Screening Pivotal Study
Recruiting
N/A
Interventional Study
HPV
HPV - Anogenital Human Papilloma Virus Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 25 – 65
- Sex
- Female
- Study type
- Interventional
- Purpose
- Screening
- Participants needed
- 260 (estimated)
- Sponsor
- Mel Mont Medical · Industry
Who this trial is looking for
This trial is looking for women aged 25 to 65 to help test a device for collecting samples that check for HPV, a virus linked to cervical cancer. Participants will follow instructions to collect their own vaginal samples and see how those results compare to samples collected by a doctor.
Are You a Good Fit for This Trial?
You may be able to join if
- I am between 25 and 65 years old.
- I have an intact cervix.
- I am willing to provide informed consent.
You may not be able to join if
- I cannot provide informed consent.
- I have had a hysterectomy.
- I have had cervical surgery or tissue changes in the last 5 months.
- I am currently pregnant.
- I am on my period when the sample is collected.
- I have had vaginal bleeding within the last 48 hours.
- I have had sex or used tampons or vaginal products in the last 48 hours.
- I have any medical reason that would prevent me from a pelvic exam.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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About This Trial
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-collect…
Trial Locations
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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.…
Contacts