Point of Care - Triage and Treatment for Cervical Pre-cancer
Recruiting
N/A
Interventional Study
Cervical Precancer
Cervical Intraepithelial Neoplasia
Human Papillomavirus Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 30 – 49
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 5,000 (estimated)
- Sponsor
- Basic Health International, Inc. · Other
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About This Trial
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 histop…
Trial Locations
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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 th…
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