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Pocket Colposcopy Using CARE Algorithm

RECRUITINGN/ASponsored by Duke University
Actively Recruiting
PhaseN/A
SponsorDuke University
Started2024-02-15
Est. completion2027-04-30
Eligibility
Age25 Years+
SexFEMALE
Healthy vol.Accepted

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

Age: 25 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions3

CancerCervical CancerHPV Infection

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