CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 434 enrolled
Drug / intervention
Pocket Colposcope +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04998318
NCT04998318N/ACompleted
CompareCT.gov

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

Duke University·interventional·Posted Aug 10, 2021·Updated Jun 24, 2025

In Brief

A clinical study evaluating Pocket Colposcope and Standard of Care Colposcopy for Cervical Cancer and 2 related conditions. Completed, enrolled 434 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Cancer, HPV Infection, HIV Infections
CountriesKenya
CollaboratorsKenya Medical Research Institute

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 10, 2021
Enrollment StartNov 28, 2022
Primary CompletionMay 16, 2024
Study CompletionJun 16, 2024
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.9 years ago

Interventions

Pocket Colposcopedevice

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.

Standard of Care Colposcopyprocedure

VIA and VILI as previously described,