NCT06458062

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,079 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Not 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.

Detailed description

Women undergo Pocket-Assisted VIA (PA-VIA) and green light imaging using the Pocket Colposcope. Women will have biopsies taken of any suspicious lesions, or two biopsies taken in random locations if no lesions are visible. The locations of the biopsies will be based on provider impression. After their study-exams and biopsies are taken, women who are eligible for ablative treatment will be immediately treated in the clinic. Those with larger lesions or lesions concerning for invasive cancer will be referred to the local hospital for an excisional procedure. Once we have obtained enough images to develop the CARE algorithm, it will also be used to assist the provider in diagnosis. This record previously reflected only Phase 1 of Aim 3 of the grant. Phase 1 of Aim 3 was originally included within NCT04998318. The details for Phase 2 of Aim 3 were added to this record in September 2025 after approval.

Conditions

• Cervical Cancer
• HPV Infection

Interventions

Type	Name	Description
DEVICE	Pocket Colposcope	Each patient will receive treatment in order to prevent cervical cancer

Timeline

• Start date: 2024-02-15
• Primary completion: 2027-04-30
• Completion: 2027-04-30
• First posted: 2024-06-13
• Last updated: 2026-01-12

Locations

1 site across 1 country: Kenya

Regulatory

• FDA-regulated device study