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

Recruiting now · Not applicable

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

In brief

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.

Key facts

Study ID

NCT07461818

Run by

Basic Health International, Inc.

People needed

5000

Starts

2026-03-01

Expected to finish

2029-08-01

Last updated by the study team

2026-03-11

Who can join

Age: 30 and older, up to 49. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Basic Health International — San Salvador, San Salvador Department, El Salvador (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.