Status:
COMPLETED
Comparison of Cervical CIN II/III Treatment Outcomes With Thermal Ablation Device
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Basic Health International
Conditions:
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 cryothera...
Detailed Description
The standard treatment for cervical pre-cancer is gas-based cryotherapy, the freezing of tissue to ablate (destroy) lesions. Although cryotherapy is relatively simple to perform, the necessary gas tan...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
1154 Patients enrolled
Trial Details
Trial ID
NCT03429582
Start Date
October 30 2020
End Date
July 1 2025
Last Update
July 17 2025
Active Locations (2)
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1
Peking University Shenzhen Hospital
Shenzhen, China
2
Hospital Nacional de la Mujer
San Salvador, El Salvador