Clinical Trial

Point of Care - Triage and Treatment for Cervical Pre-cancer

Study acronym: POC
Recruiting
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Summary
This study evaluates a modified two-probe thermal ablation protocol using the IRIS™ device and retrospectively assesses an AI-based Automated Visual Evaluation (AVE) triage algorithm among HPV-positive women in El Salvador. The primary objective is to estimate 1-year cure rates of CIN2+ following treatment. A secondary objective is to evaluate the diagnostic performance of AVE compared with histopathology.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-05.
Trial Details
NCT Number NCT07461818
Lead Sponsor Basic Health International, Inc.
Collaborators: The Cleveland Clinic, Liger Medical Llc, Medical College of Wisconsin
Conditions Cervical Precancer, Cervical Intraepithelial Neoplasia, Human Papillomavirus Infection
Enrollment 5,000 participants
Start Date 2026-03
Primary Completion 2029-01 (estimated)
Study Completion 2029-08 (estimated)
Updated on ClinicalTrials.gov 2026-03-11