RecruitingNot ApplicableNCT06458062

Pocket Colposcopy Using CARE Algorithm

Development and Validation of an Artificial-Intelligence-enabled Portable Colposcopy Device for Optimizing Triage Alternatives for HPV-based Cervical Cancer Screening

Sponsor

Duke University

Enrollment

1,079 participants

Start Date

Feb 15, 2024

Study Type

INTERVENTIONAL

Conditions

Cervical Cancer HPV Infection

Summary

The Pocket colposcope has 510k FDA clearance and has been successfully used in \~2500 unique patients globally in Duke and non-Duke protocols to date. 1054 women who are HPV(+) and planned to undergo treatment at four Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be proceed with colposcopy using the POCKET colposcope.

Eligibility

Sex: FEMALEMin Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a small handheld device (called a "pocket colposcope") combined with an image analysis system (CARE algorithm) can accurately detect abnormal cervical cells in women with a positive HPV test, as an alternative to standard colposcopy performed in a clinic. **You may be eligible if...** - You are between 30 and 64 years old (or 25–64 if you are HIV-positive) - You are female - You had a positive HPV test within the past 6 months **You may NOT be eligible if...** - You are pregnant - You had a negative HPV test within the past 9 months - You have a history of cervical cancer - You are unable to give informed consent - Your pelvic exam raises concerns about cervical cancer already Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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