Point of Care - Triage and Treatment for Cervical Pre-cancer
POINT of CARE - Providing an Innovative New Triage and Treatment Strategy for Cervical Cancer Screening Efficiency
Basic Health International, Inc.
5,000 participants
Mar 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Women aged 30-49 years
- Non-pregnant (determined by urine pregnancy test)
- HPV-positive per Ministry of Health (MOH) records
- Willing to undergo colposcopy and biopsies
- Able and willing to provide informed consent
Exclusion Criteria6
- Plans to become pregnant during the study
- History of LEEP or cervical ablation procedure in the past 5 years
- History of total hysterectomy (verified by medical record or pelvic evaluation)
- History of cervical cancer
- Unable or unwilling to provide a permanent and reliable address
- Unable or unwilling to provide informed consent
Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT07461818