POINT of CARE - Providing an Innovative New Triage and Treatment Strategy for Cervical Cancer Screening Efficiency
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 49
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
El Salvador
Basic Health International
RECRUITING
San Salvador
Contact Information
Primary
Karla Alfaro, MD
kalfaro@basichealth.org
+503 22838731
Time Frame
Start Date: 2026-03
Estimated Completion Date: 2029-08
Participants
Target number of participants: 5000
Treatments
Experimental: Two-Probe Thermal Ablation Using IRIS™
Participants eligible for ablation will undergo thermal ablation using the IRIS™ device with a modified two-probe protocol. The short endocervical probe will be positioned in the distal canal (just inside the cervical os) for 20 seconds at 100°C, followed by placement of the appropriate-sized flat ectocervical probe in overlapping applications of 20 seconds at 100°C until the entire squamocolumnar junction is treated.
Related Therapeutic Areas
Sponsors
Leads: Basic Health International, Inc.
Collaborators: Liger Medical Llc, Medical College of Wisconsin, The Cleveland Clinic