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

RecruitingNAAges 30 Years - 49 YearsFemaleBasic Health International, Inc.
NCT07461818 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • IRIS™ Thermal Ablation Device
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Where

1 site
Basic Health International
San Salvador, El Salvador
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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