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Completed
NCT03429582
Comparison of Cervical CIN II/III Treatment Outcomes With Thermal Ablation Device
Conditions: Cervical Intraepithelial Neoplasia
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1154
Sponsor: The Cleveland Clinic
Location: Peking University Shenzhen Hospital Shenzhen
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.
Eligibility Criteria
Criteria for inclusion
* Women aged 18 and older
* Biopsy results of CIN2, CIN2-3, CIN3, or high-grade CIN not otherwise specified
* Willing and able to provide informed consent
* Willing and able to provide permanent or reliable address
Criteria for exclusion
* Pregnant or plans to become pregnant during study
* History of total hysterectomy (verified by medical record or pelvic evaluation)
* Previous surgery destructive to the cervix within the last 5 years
* Patient not eligible for cryotherapy or thermoablation (lesion \>75% of cervix, lesion extends into canal or there is suspicion for invasive cancer)
* Cervix shape disfigured or hard to reach
Source: ClinicalTrials.gov (NCT03429582). StuddyBuddy aggregates publicly available trial information.