An Innovative Treatment for Cervical Pre Cancer
- Conditions
- Cervical Intraepithelial Neoplasia
- Interventions
- Device: CryoPenDevice: CO2 standard cryotherapyDevice: Thermocoagulator
- Registration Number
- NCT02814448
- Lead Sponsor
- The Cleveland Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 130
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CryoPen- single freeze CryoPen Single freeze treatment consists of one five-minute freeze CO2 standard cryotherapy- single freeze CO2 standard cryotherapy Single freeze treatment consists of one five-minute freeze CryoPen- double freeze CryoPen Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze CO2 standard cryotherapy- double freeze CO2 standard cryotherapy Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze Thermocoagulator Thermocoagulator Single heat application at 100 ºC for 40 seconds
- Primary Outcome Measures
Name Time Method Mean Depth of Necrosis Achieved With the LMIC-adapted CryoPen and the Thermocoagulator Compared to Mean Depth of Necrosis Achieved With CO2-based Cryotherapy 24-48 hours after treatment
- Secondary Outcome Measures
Name Time Method Mean Pain During Treatment Reported by Patients Treated With Double and Single Freeze CO2 Cryotherapy, Double and Single Freeze CryoPen and Thermoablation 40 seconds to 13 minutes Scale Title: Pain scale during treatment Minimal value = 0 (no pain) Maximum value = 10 (most pain) This is a one item 11-point scale to measure self-reported pain during each of the treatments which lasted between 40 seconds (thermoablation) and 13 minutes (double freeze cryotherapy and double freeze CryoPen).
Trial Locations
- Locations (2)
Instituto Nacional de Enfermedades Neoplásicas
🇵🇪Lima, Peru
Hospital 1 de Mayo del Instituto Salvadoreño del Seguro Social
🇸🇻San Salvador, El Salvador