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1:1 Comparison of the Pocket Colposcope in Kenya

NCT04998318 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 434

Last updated 2025-06-24

Study results available
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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

Conditions

Interventions

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,

Sponsors & Collaborators

  • Kenya Medical Research Institute

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Megan Huchko, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-28
Primary Completion
2024-05-16
Completion
2024-06-16
FDA Device
Yes

Countries

  • Kenya

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04998318 on ClinicalTrials.gov