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Comparison of Cervical CIN II/III Treatment Outcomes With Thermal Ablation Device
Sponsor: The Cleveland Clinic
Summary
The purpose of this academic-industrial partnership will be to compare two thermoablation modalities using devices adapted to low and middle income countries (LMICs) to traditional CO2-based cryotherapy for the treatment of cervical precancer. The investigators will 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.
Official title: Comparison of Cervical Intraepithelial Neoplasia 2/3 Treatment Outcomes With a Portable LMIC-adapted Thermal Ablation Device vs. Gas-based Cryotherapy
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1154
Start Date
2020-10-30
Completion Date
2025-07-01
Last Updated
2026-08-03
Healthy Volunteers
No
Conditions
Interventions
Standard C02 Cryotherapy
Standard therapy using carbon dioxide for freezing of tissue
Single Tip Thermoablation
Thermoablator outfitted with a 19mm conical tip
Multiple Tip Thermoablation
Thermoablator outfitted with detachable probes
Locations (2)
Peking University Shenzhen Hospital
Shenzhen, China
Hospital Nacional de la Mujer
San Salvador, El Salvador