Brief Title
An Innovative Treatment for Cervical Pre Cancer
Official Title
CryoPen: An Innovative Treatment for Cervical Precancer in Low-Resource Settings
Brief 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.
Study Type
Interventional
Primary Outcome
Mean Depth of Necrosis Achieved With the LMIC-adapted CryoPen and the Thermocoagulator Compared to Mean Depth of Necrosis Achieved With CO2-based Cryotherapy
Secondary Outcome
Mean Pain During Treatment Reported by Patients Treated With Double and Single Freeze CO2 Cryotherapy, Double and Single Freeze CryoPen and Thermoablation
Condition
Cervical Intraepithelial Neoplasia
Intervention
CryoPen
Study Arms / Comparison Groups
CO2 standard cryotherapy- double freeze
Description: Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
130
Start Date
February 2016
Completion Date
December 2016
Primary Completion Date
December 2016
Eligibility Criteria
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
Gender
Female
Ages
25 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Miriam Cremer, MD, ,
Location Countries
El Salvador
Location Countries
El Salvador
Administrative Informations
NCT ID
NCT02814448
Organization ID
15-296
Secondary IDs
UH2CA189883
Responsible Party
Sponsor
Study Sponsor
The Cleveland Clinic
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Miriam Cremer, MD, Principal Investigator, The Cleveland Clinic
Verification Date
October 2018