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Point of Care - Triage and Treatment for Cervical Pre-cancer
Sponsor: Basic Health International, Inc.
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.
Official title: POINT of CARE - Providing an Innovative New Triage and Treatment Strategy for Cervical Cancer Screening Efficiency
Key Details
Gender
FEMALE
Age Range
30 Years - 49 Years
Study Type
INTERVENTIONAL
Enrollment
5000
Start Date
2026-03
Completion Date
2029-08
Last Updated
2026-03-11
Healthy Volunteers
No
Interventions
IRIS™ Thermal Ablation Device
Thermal ablation will be performed using the IRIS™ device with a modified two-probe protocol. The short endocervical probe will be positioned in the distal canal for 20 seconds at 100°C, followed by overlapping applications of the appropriate-sized flat ectocervical probe for 20 seconds at 100°C until the entire squamocolumnar junction is treated.
Locations (1)
Basic Health International
San Salvador, San Salvador Department, El Salvador