RecruitingNot Applicable

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

El Salvador5,000 participantsStarted 2026-03

Plain-language 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.

Who can participate

Age range30 Years – 49 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

1-Year Cure Rate of CIN2+

Timeframe: 12 months after treatment

Trial details

NCT IDNCT07461818

SponsorBasic Health International, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01

Contact for this trial

Karla Alfaro, MD

+503 22838731 kalfaro@basichealth.org

View on ClinicalTrials.gov More Cervical Precancer trials