Evaluating IRIS Device for Treating Cervical Precancer and AI-Based Visual Triage in HPV-Positive Women Ages 30 to 49

What this Trial Is About

Researchers are evaluating a modified thermal ablation treatment using the IRIS173 device and an AI-based Automated Visual Evaluation AVE triage algorithm among HPV-positive women in El Salvador. This study aims to estimate the 1-year cure rates of cervical intraepithelial neoplasia grade 2 or higher CIN2 after treatment and to assess how well the AVE algorithm identifies high-risk cervical images compared to tissue analysis. The trial addresses the need for improved protocols in treating cervical precancer with portable thermal ablation devices in low-resource settings. Participants eligible for ablation will receive thermal ablation using the IRIS173 device with a modified two-probe protocol. The treatment involves placing a short endocervical probe inside the cervical canal for 20 seconds at 1001730C, followed by overlapping applications of a flat ectocervical probe for 20 seconds each until the entire targeted area is treated. Some women will be monitored for side effects at 6 weeks and for safety at 4-6 months post-treatment. Women not eligible for ablation will be referred for standard care. A retrospective analysis will also evaluate the AVE algorithms performance using cervical images and biopsy results. Participants will undergo an initial visit with HPV genotyping, visual assessment, colposcopy, biopsies, and endocervical curettage. Those treated will be asked to return at one year for follow-up testing including HPV genotyping and biopsies to check for persistent disease. A subsample will have additional visits for safety monitoring. Biopsy samples will be reviewed by expert pathologists to confirm diagnoses. Researchers will measure cure rates, side effects, participant acceptability, and diagnostic accuracy of the AVE algorithm, with the total study duration lasting up to one year post-treatment for most participants.

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