Point of Care - Triage and Treatment for Cervical Pre-cancer
POC
POINT of CARE - Providing an Innovative New Triage and Treatment Strategy for Cervical Cancer Screening Efficiency
2 other identifiers
interventional
5,000
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2026
CompletedFirst Submitted
Initial submission to the registry
March 5, 2026
CompletedFirst Posted
Study publicly available on registry
March 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2029
March 11, 2026
March 1, 2026
2.8 years
March 5, 2026
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1-Year Cure Rate of CIN2+
Cure rate defined as histopathologic diagnosis of \<CIN2 one year after treatment with the IRIS™ modified two-probe approach.
12 months after treatment
Secondary Outcomes (5)
Diagnostic Performance of AVE Algorithm
Baseline (initial visit cervical images compared with histopathology results)
Extreme Misclassification Rate of the AVE Algorithm
Baseline (initial visit cervical images compared with histopathology results)
Rate of Serious Side Effects Following Thermal Ablation
6 weeks after treatment
Participant Acceptability of Thermal Ablation Treatment
Immediately after treatment
Persistence of CIN2+ at Early Safety Follow-Up
4-6 months after treatment
Study Arms (1)
Two-Probe Thermal Ablation Using IRIS™
EXPERIMENTALParticipants eligible for ablation will undergo thermal ablation using the IRIS™ device with a modified two-probe protocol. The short endocervical probe will be positioned in the distal canal (just inside the cervical os) for 20 seconds at 100°C, followed by placement of the appropriate-sized flat ectocervical probe in overlapping applications of 20 seconds at 100°C until the entire squamocolumnar junction is treated.
Interventions
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Basic Health International, Inc.lead
- The Cleveland Cliniccollaborator
- Liger Medical Llccollaborator
- Medical College of Wisconsincollaborator
Study Sites (1)
Basic Health International
San Salvador, San Salvador Department, El Salvador
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karla Alfaro, MD
Basic Health International, Inc.
- PRINCIPAL INVESTIGATOR
Rachel Masch, MD
Basic Health International, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director
Study Record Dates
First Submitted
March 5, 2026
First Posted
March 10, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
August 1, 2029
Last Updated
March 11, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- All materials will be available after study analysis is finished. The data will be made available five years from the last date of access.
Cervical images, AVE analysis results, HPV genotype, and colposcopy and biopsy correlates may be shared with teams that are working on AVE development in order to optimize the technology. During the informed consent procedure, patients will have the opportunity to accept or decline having their cervical images captured and shared. Women who decline may still participate in the rest of the research. Shared data will be de-identified; that is, it will only contain participants' study ID code and no information that can personally identify them. De-identified data will be stored in an NCI repository such as the Clinical and Translational Data Commons or the Cancer research Data Commons.