An Innovative Treatment for Cervical Pre Cancer

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

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.

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.

Inclusion Criteria:

• Between 25 and 65 years old.
• Scheduled for a hysterectomy for reasons other than cervical precancer or cancer
• Diagnosis of uterine, endometrial, ovarian or other cancer that does not jeopardize the tissue of the cervix is permitted
• Histological evaluation of the cervix does not interfere with the woman's current diagnosis
• Woman consents to participate after being informed about the study
• Normal Pap Smear or HPV test in the past 3 years

Exclusion Criteria:

• Pregnancy
• History of cervical surgery in past 5 years
• Presence of cervical lesion pre-invasive or invasive on the cervix *
• Current Pelvic Inflammatory Disorder or severe acute cervicitis
• Cervix shape disfigured or hard to reach