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

Conditions: Cervical Precancer, Cervical Intraepithelial Neoplasia, Human Papillomavirus Infection

Sex: Female

Ages: 30 Years – 49 Years

Healthy volunteers: No

Phase: NA

Enrollment: 5000

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.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07461818). StuddyBuddy aggregates publicly available trial information.