NCT06458062Recruiting
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
Source: ClinicalTrials.gov · Last updated 12 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1079 (estimated)
- First submitted
- 10 Jun 2024
- Start date
- 15 Feb 2024
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Duke University
- Diseases
- Cervical cancer
- NCT number
- NCT06458062
What you commit to
- Study type: Interventional
- Planned participants: 1079
- From 15 Feb 2024 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Women with a history of cervical cancer
- Pelvic exam concerning for cervical cancer or cervical infection
- History of hysterectomy
Other
- 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
Who the study is looking for
- 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
Age in the registry: 25 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kenya Medical Research Institute Coordinator of this site? Confirm its status | Nairobi | Kenya | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.