At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Controlled Trial Comparing Cure Rates of Cervical Intraepithelial Neoplasia Grade 2 and Higher (CIN2+) Treated With CO2-based Cryotherapy, CropPen, and Thermoablation (UH3)
In Brief
A clinical study evaluating CO2 standard therapy, CryoPen, and 1 other intervention for Cervical Intraepithelial Neoplasia. Completed, enrolled 1,132 participants across 3 sites in 3 countries.
Detailed Summary
The purpose of this academic-industrial partnership will compare the CryoPen® and thermoablator to traditional CO2-based cryotherapy for the treatment of cervical precancer in low and middle income countries (LMICs) and investigate whether the cure rates of cervical intraepithelial neoplasia 2 and more severe diagnoses (CIN2+) with these devices are non-inferior compared to that of conventional cryotherapy. The results of this study will affect other research areas by serving as a springboard to exploring treatment alternatives that are amenable to low-resource settings and thus will reach the most vulnerable populations.
Study Details
Timeline
Interventions
Standard therapy using carbon dioxide for freezing of tissue
Provides a means of freezing tissue without the use of gases or liquids
Thermoablation