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An Innovative Treatment for Cervical Pre Cancer — CryoPen  

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:
CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource Settings

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02814448
Study type Interventional
Source The Cleveland Clinic
Contact
Status Completed
Phase N/A
Start date February 2016
Completion date December 2016
View Details
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