Point of Care - Triage and Treatment for Cervical Pre-cancer
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
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
Treatments tested in this trial
- IRIS™ Thermal Ablation Device
Treatment groups
5,000 Participants
are divided into 1 treatment groupSponsors and collaborators
Basic Health International, Inc.
Lead sponsor
The Cleveland Clinic
Collaborator
Liger Medical Llc
Collaborator
Medical College of Wisconsin
Collaborator
Source ClinicalTrials.gov