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Recruiting NCT06458062

Pocket Colposcopy Using CARE Algorithm

Trial Parameters

Condition Cervical Cancer
Sponsor Duke University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,079
Sex FEMALE
Min Age 25 Years
Max Age N/A
Start Date 2024-02-15
Completion 2027-04-30
Interventions
Pocket Colposcope

Brief 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 Criteria

Inclusion Criteria: 1. Age ≥ 30 years old and ≤ 64 years old; or Age ≥ 25 years old if women living with HIV (WLWH) 2. Sex: Female 3. Positive HPV test within past 6 months Exclusion Criteria: 1. Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated) 2. Women with a negative HPV test within the past 9 months 3. Patients incapable of giving informed consent 4. Women with a history of cervical cancer 5. Pelvic exam concerning for cervical cancer or cervical infection 6. History of hysterectomy

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