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.
Mean Depth of Necrosis Achieved With the LMIC-adapted CryoPen and the Thermocoagulator Compared to Mean Depth of Necrosis Achieved With CO2-based Cryotherapy
Mean Pain During Treatment Reported by Patients Treated With Double and Single Freeze CO2 Cryotherapy, Double and Single Freeze CryoPen and Thermoablation
Cervical Intraepithelial Neoplasia
Study Arms / Comparison Groups
CO2 standard cryotherapy- double freeze
Description: Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
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
25 Years - 65 Years
Accepts Healthy Volunteers
Miriam Cremer, MD, ,
The Cleveland Clinic
National Cancer Institute (NCI)
Miriam Cremer, MD, Principal Investigator, The Cleveland Clinic