Health Trials

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

ConditionsCervical PrecancerCervical Intraepithelial NeoplasiaHuman Papillomavirus Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-49
SponsorBasic Health International, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • IRIS™ Thermal Ablation Device

    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.

Treatment groups

5,000 Participants
are divided into 1 treatment group
Group A: Two-Probe Thermal Ablation Using IRIS™Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
12 months after treatment

Secondary outcomes

1

Diagnostic Performance of AVE Algorithm

Diagnostic performance of the AVE algorithm will be evaluated by comparing AVE image classifications ("normal," "indeterminate," or "severe") with histopathologic diagnosis as the reference standard. Performance will be quantified using the Area Under the Receiver Operating Characteristic Curve (AUC-ROC), which assesses the algorithm's ability to distinguish cervical intraepithelial neoplasia grade 2 or higher (CIN2+) from less severe findings across classification thresholds. AVE analysis will be conducted retrospectively and will not influence real-time clinical management decisions.

Time frame
Baseline (initial visit cervical images compared with histopathology results)
2

Extreme Misclassification Rate of the AVE Algorithm

The proportion of extreme misclassifications by the AVE algorithm will be assessed. Extreme misclassification is defined as a two-class error (e.g., normal histopathology classified as severe by AVE). The algorithm will be evaluated to ensure extreme misclassification occurs in less than 5% of cases.

Time frame
Baseline (initial visit cervical images compared with histopathology results)
3

Rate of Serious Side Effects Following Thermal Ablation

Serious side effects will include serious adverse events (SAEs), cervical stenosis (defined as inability to pass a cytobrush through the cervical os), or infection requiring intravenous antibiotics. These events will be assessed during the 6-week follow-up visit among a subset of participants treated with thermal ablation.

Time frame
6 weeks after treatment
4

Participant Acceptability of Thermal Ablation Treatment

Participant perceptions of treatment acceptability will be assessed using a brief questionnaire evaluating pain, comfort, perceived effectiveness, ease of treatment, and overall satisfaction. Pain will be measured using the Wong-Baker Faces Pain Rating Scale, a validated self-report pain assessment tool with scores ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain possible." Higher scores indicate greater pain and lower treatment acceptability.

Time frame
Immediately after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Basic Health International, Inc.

Lead sponsor

The Cleveland Clinic

Collaborator

Liger Medical Llc

Collaborator

Medical College of Wisconsin

Collaborator

Source ClinicalTrials.gov
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