Testing a Portable AI Colposcope for Cervical Cancer Screening
Tests a small portable device with AI to examine the cervix in women with HPV.
Plain-language title generated from the registry record
Registry title: Pocket Colposcopy Using CARE Algorithm
Key facts
- Where
- Nairobi, KenyaSee the site
Where in Kenya
- Kenya Medical Research InstituteNairobi, KenyaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Duke University
- Trial code
- NCT06458062
- Record updated
- 12 January 2026
- Original description
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.Read full original descriptionShow less
Development and Validation of an Artificial-Intelligence-enabled Portable Colposcopy Device for Optimizing Triage Alternatives for HPV-based Cervical Cancer Screening
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.
Inclusion: Age ≥ 30 years old and ≤ 64 years old; or Age ≥ 25 years old if women living with HIV (WLWH); Sex: Female; Positive HPV test within past 6 months.
Exclusion: Women with a history of cervical cancer; Pelvic exam concerning for cervical cancer or cervical infection; History of hysterectomy; Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated); Women with a negative HPV test within the past 9 months; Patients incapable of giving informed consent.