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

NCT07461818 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5000

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

  • Cervical Precancer
  • Cervical Intraepithelial Neoplasia
  • Human Papillomavirus Infection

Interventions

DEVICE

IRIS™ Thermal Ablation Device

Thermal ablation will be performed using the IRIS™ device with a modified two-probe protocol. The short endocervical probe will be positioned in the distal canal for 20 seconds at 100°C, followed by overlapping applications of the appropriate-sized flat ectocervical probe for 20 seconds at 100°C until the entire squamocolumnar junction is treated.

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • Liger Medical Llc

    collaborator UNKNOWN

  • Medical College of Wisconsin

    collaborator OTHER

  • Basic Health International, Inc.

    lead OTHER

Principal Investigators

  • Karla Alfaro, MD · Basic Health International, Inc.

  • Rachel Masch, MD · Basic Health International, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2029-01-31
Completion
2029-08-31
FDA Device
Yes

Countries

  • El Salvador

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07461818 on ClinicalTrials.gov