An Innovative Treatment for Cervical Pre Cancer
An Innovative Treatment for Cervical Pre Cancer
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