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

RECRUITINGN/ASponsored by Basic Health International, Inc.
Actively Recruiting
PhaseN/A
SponsorBasic Health International, Inc.
Started2026-03
Est. completion2029-01
Eligibility
Age30 Years – 49 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07461818

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

Age: 30 Years – 49 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions4

CancerCervical Intraepithelial NeoplasiaCervical PrecancerHuman Papillomavirus Infection

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