NCT04998318

1:1 Comparison of the Pocket Colposcope in Kenya

Compare the Performance of the Pocket Colposcope to VIA/VILI for Triage of HPV+ Women in Kenya

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 434 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The Pocket colposcope has 510k FDA clearance and has been successfully used in almost 1500 unique patients globally in Duke and non-Duke protocols to date. 400 women who are HPV-positive and planned to undergo treatment at 6 Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be randomized 1:1 to either standard-of-care visual inspection or colposcopy with the Pocket Colposcope

Detailed description

Women randomized to the standard-of-care arm will undergo VIA followed by Visual Inspection with Lugol's Iodine (VILI). Women randomized to the Pocket Colposcope arm will undergo Pocket-Assisted VIA (PA-VIA), green light imaging, and VILI using the Pocket Colposcope. Women in both arms 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.

Conditions

• Cervical Cancer
• HPV Infection
• HIV Infections

Interventions

Type	Name	Description
DEVICE	Pocket Colposcope	Both arms will receive treatment in order to prevent cervical cancer. However, the intervention using the pocket colposcope device will be used on half the enrolled subjects.
PROCEDURE	Standard of Care Colposcopy	VIA and VILI as previously described,

Timeline

• Start date: 2022-11-28
• Primary completion: 2024-05-16
• Completion: 2024-06-16
• First posted: 2021-08-10
• Last updated: 2025-06-24
• Results posted: 2025-06-24

Locations

1 site across 1 country: Kenya

Regulatory

• FDA-regulated device study