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Pocket Colposcopy Using CARE Algorithm
Sponsor: Duke University
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.
Official title: Development and Validation of an Artificial-Intelligence-enabled Portable Colposcopy Device for Optimizing Triage Alternatives for HPV-based Cervical Cancer Screening
Key Details
Gender
FEMALE
Age Range
25 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1079
Start Date
2024-02-15
Completion Date
2027-04-30
Last Updated
2026-01-12
Healthy Volunteers
No
Conditions
Interventions
Pocket Colposcope
Each patient will receive treatment in order to prevent cervical cancer
Locations (1)
Kenya Medical Research Institute
Nairobi, Kenya