An Innovative Treatment for Cervical Pre Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Intraepithelial Neoplasia

Intervention / Treatment
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* Device: CryoPen
* Device: CO2 standard cryotherapy
* Device: Thermocoagulator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CO2 standard cryotherapy- double freeze<br>Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze | Device: CO2 standard cryotherapy<br>* Standard therapy using carbon dioxide for freezing of tissue<br>|
| Active Comparator: CO2 standard cryotherapy- single freeze<br>Single freeze treatment consists of one five-minute freeze | Device: CO2 standard cryotherapy<br>* Standard therapy using carbon dioxide for freezing of tissue<br>|
| Active Comparator: CryoPen- double freeze<br>Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze | Device: CryoPen<br>* Provides a means of freezing tissue without the use of gases or liquids<br>|
| Active Comparator: CryoPen- single freeze<br>Single freeze treatment consists of one five-minute freeze | Device: CryoPen<br>* Provides a means of freezing tissue without the use of gases or liquids<br>|
| Experimental: Thermocoagulator<br>Single heat application at 100 ºC for 40 seconds | Device: Thermocoagulator<br>* The use of heat produced by high-frequency electric current to bring about local destruction of tissues<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Pain During Treatment Reported by Patients Treated With Double and Single Freeze CO2 Cryotherapy, Double and Single Freeze CryoPen and Thermoablation | 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). | 40 seconds to 13 minutes |