Comparative Self-collection for Cervical Cancer Screening Pivotal Study
NCT07758140
This study is recruiting at 11 US sites in 8 states, according to its ClinicalTrials.gov record last updated .
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).
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- HPV
- HPV - Anogenital Human Papilloma Virus Infection
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Not applicable
- Ages
- 25 to 65 years
- Sex
- Female
- Healthy volunteers
- Accepted
- Sponsor
- Mel Mont Medical
- Last updated on ClinicalTrials.gov
- August 11, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Arizona · 1
- ASR Arizona CGA · Phoenix, AZ
California · 1
- Integrated Clinical Research · Sherman Oaks, CA
Florida · 2
- Altus Clinical Research · Lake Worth, FL
- Zenacare Research · North Miami Beach, FL
Idaho · 1
- ASR Idaho CGI · Boise, ID
Montana · 1
- Boeson Research - Great Falls · Great Falls, MT
North Carolina · 3
- Unified Women's Clinical Research · Raleigh, NC
- Innovo-Wilmington Health · Wilmington, NC
- Lyndhurst Clinical Research (Unified) · Winston-Salem, NC
Texas · 1
- El Centro de Corazon · Houston, TX
Washington · 1
- National Eagle Research · Lynnwood, WA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.