Clinical trial · Interventional
Point of Care - Triage and Treatment for Cervical Pre-cancer
POINT of CARE - Providing an Innovative New Triage and Treatment Strategy for Cervical Cancer Screening Efficiency
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Cervical Precancer | — | UNRESOLVED | — |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IRIS™ Thermal Ablation Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Two-Probe Thermal Ablation Using IRIS™
- description
- Participants 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.
- interventionNames
- Device: IRIS™ Thermal Ablation Device
Primary outcomes (1)
- measure
- 1-Year Cure Rate of CIN2+
- timeFrame
- 12 months after treatment
- description
- Cure rate defined as histopathologic diagnosis of \<CIN2 one year after treatment with the IRIS™ modified two-probe approach.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 49 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available