Actively Recruiting
POINT of CARE - Providing an Innovative New Triage and Treatment Strategy for Cervical Cancer Screening Efficiency
Led by Basic Health International, Inc. · Updated on 2026-03-11
5000
Participants Needed
1
Research Sites
30 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
Researchers are evaluating a modified thermal ablation treatment using the IRIS173 device and an AI-based Automated Visual Evaluation (AVE) triage algorithm among HPV-positive women in El Salvador. This study aims to estimate the 1-year cure rates of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) after treatment and to assess how well the AVE algorithm identifies high-risk cervical images compared to tissue analysis. The trial addresses the need for improved protocols in treating cervical precancer with portable thermal ablation devices in low-resource settings. Participants eligible for ablation will receive thermal ablation using the IRIS173 device with a modified two-probe protocol. The treatment involves placing a short endocervical probe inside the cervical canal for 20 seconds at 1001730C, followed by overlapping applications of a flat ectocervical probe for 20 seconds each until the entire targeted area is treated. Some women will be monitored for side effects at 6 weeks and for safety at 4-6 months post-treatment. Women not eligible for ablation will be referred for standard care. A retrospective analysis will also evaluate the AVE algorithm's performance using cervical images and biopsy results. Participants will undergo an initial visit with HPV genotyping, visual assessment, colposcopy, biopsies, and endocervical curettage. Those treated will be asked to return at one year for follow-up testing including HPV genotyping and biopsies to check for persistent disease. A subsample will have additional visits for safety monitoring. Biopsy samples will be reviewed by expert pathologists to confirm diagnoses. Researchers will measure cure rates, side effects, participant acceptability, and diagnostic accuracy of the AVE algorithm, with the total study duration lasting up to one year post-treatment for most participants.
CONDITIONS
Brief 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
- Not pregnant as confirmed by urine pregnancy test
- HPV-positive according to Ministry of Health records
- Willing to undergo colposcopy and biopsies
- Able and willing to provide informed consent
You will not qualify if you...
- Planning to become pregnant during the study
- History of LEEP or cervical ablation procedure within the past 5 years
- History of total hysterectomy confirmed 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment visit
Participants eligible for ablation will undergo thermal ablation using the IRIS™ device with a modified two-probe protocol. The endocervical probe is applied for 20 seconds at 100°C, followed by overlapping applications of the ectocervical probe until the treatment area is fully covered.
1 visit (in-person)
Duration - Up to 6 weeks post-treatment
A subsample of participants will return to monitor for potential side effects and evaluate the safety of the two-probe treatment protocol.
1 to 2 visits (in-person) depending on safety monitoring schedule
Duration - 12 months after treatment
Participants with biopsy-confirmed CIN2+ at baseline will return for follow-up to assess treatment effectiveness with HPV testing, colposcopy, biopsy, and endocervical curettage one year after treatment.
1 visit (in-person)
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
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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