RecruitingNot ApplicableNCT07461818

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

Sponsor

Basic Health International, Inc.

Enrollment

5,000 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Cervical Intraepithelial Neoplasia Human Papillomavirus Infection Cervical Precancer

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

Sex: FEMALEMin Age: 30 YearsMax Age: 49 Years

Plain Language Summary

Simplified for easier understanding

This trial evaluates a "screen-and-treat" approach at the point of care for women with abnormal HPV results, offering colposcopy and immediate treatment to prevent cervical cancer from developing. **You may be eligible if...** - You are a woman between 30 and 49 years old - You have tested positive for HPV according to Ministry of Health records - You are not currently pregnant (confirmed by urine test) - You are willing to have a colposcopy and biopsies - You can provide informed consent **You may NOT be eligible if...** - You plan to become pregnant during the study - You have had a LEEP or cervical ablation procedure in the past 5 years - You have had a full hysterectomy - You have a history of cervical cancer - You cannot provide a reliable address or are unwilling to give consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIRIS™ 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.