NCT02814448

An Innovative Treatment for Cervical Pre Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: Female
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
DEVICE	CryoPen	Provides a means of freezing tissue without the use of gases or liquids
DEVICE	CO2 standard cryotherapy	Standard therapy using carbon dioxide for freezing of tissue
DEVICE	Thermocoagulator	The use of heat produced by high-frequency electric current to bring about local destruction of tissues

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-06-27
• Last updated: 2018-11-20
• Results posted: 2018-11-20

Locations

2 sites across 2 countries: El Salvador, Peru