1:1 Comparison of the Pocket Colposcope in Kenya

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04998318
Study type	Interventional
Source	Duke University
Contact	Megan Huchko, MD
Phone	919-684-8111
Email	megan.huchko@duke.edu
Status	Recruiting
Phase	N/A
Start date	November 28, 2022
Completion date	April 2024

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