Actively Recruiting
Point of Care - Triage and Treatment for Cervical Pre-cancer
Led by Basic Health International, Inc. · Updated on 2026-03-11
5000
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
Sponsors
B
Basic Health International, Inc.
Lead Sponsor
T
The Cleveland Clinic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Point of Care - Triage and Treatment for Cervical Pre-cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 30-49 years
- Non-pregnant (determined by urine pregnancy test)
- HPV-positive per Ministry of Health records
- Willing to undergo colposcopy and biopsies
- Able and willing to provide informed consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Basic Health International
San Salvador, San Salvador Department, El Salvador
Actively Recruiting
Research Team
K
Karla Alfaro, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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