Spots Global Cancer Trial Database for An Innovative Treatment for Cervical Pre Cancer
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Trial Identification
Brief Title: An Innovative Treatment for Cervical Pre Cancer
Official Title: CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource Settings
Study ID: NCT02814448
Conditions
Study Description
Brief Summary: The purpose of this study is to test two innovative devices, the CryoPen® and thermocoagulator, against gas-based cryotherapy to determine whether the novel devices produce equivalent or improved destruction of cervical tissue compared to gas-based cryotherapy. Tissue destruction with single freeze versus double freeze treatments with the CryoPen and gas-based cryotherapy will also be compared.
Detailed Description: The primary objectives of the study are to test the hypothesis that the CryoPen® and thermocoagulator provide a non-inferior depth of cervical tissue necrosis compared with traditional CO2-based cryotherapy and to test single versus double freeze applications. The secondary objectives of the study are to determine if the CryoPen® or thermocoagulator achieves a depth of necrosis of 3.5 mm, the accepted depth required for eradicating 95% of cervical precancer, and to observe the relationship between depth of necrosis and variations in cervical anatomy.
Keywords
Eligibility
Minimum Age: 25 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Hospital 1 de Mayo del Instituto Salvadoreño del Seguro Social, San Salvador, , El Salvador
Instituto Nacional de Enfermedades Neoplásicas, Lima, , Peru
Contact Details
Name: Miriam Cremer, MD
Affiliation: The Cleveland Clinic
Role: PRINCIPAL_INVESTIGATOR
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