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| ID | Type | Description | Link |
|---|---|---|---|
| UH2CA189883 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Basic Health International, Inc. | OTHER |
| CryoPen, Inc. | OTHER |
| University of Southern California |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CO2 standard cryotherapy- double freeze | Active Comparator | Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze |
|
| CO2 standard cryotherapy- single freeze | Active Comparator | Single freeze treatment consists of one five-minute freeze |
|
| CryoPen- double freeze | Active Comparator | Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze |
|
| CryoPen- single freeze | Active Comparator | Single freeze treatment consists of one five-minute freeze |
|
| Thermocoagulator | Experimental | Single heat application at 100 ºC for 40 seconds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CryoPen | Device | Provides a means of freezing tissue without the use of gases or liquids |
|
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miriam Cremer, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital 1 de Mayo del Instituto Salvadoreño del Seguro Social | San Salvador | El Salvador | ||||
| Instituto Nacional de Enfermedades Neoplásicas |
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Participants were between the ages of 25 and 65 to be eligible for the study
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| ID | Title | Description |
|---|---|---|
| FG000 | CO2 Standard Cryotherapy- Double Freeze | Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue |
| FG001 | CO2 Standard Cryotherapy- Single Freeze | Single freeze treatment consists of one five-minute freeze CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue |
| FG002 | CryoPen- Double Freeze | Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze CryoPen: Provides a means of freezing tissue without the use of gases or liquids |
| FG003 | CryoPen- Single Freeze | Single freeze treatment consists of one five-minute freeze CryoPen: Provides a means of freezing tissue without the use of gases or liquids |
| FG004 | Thermocoagulator | Single heat application at 100 ºC for 40 seconds Thermocoagulator: The use of heat produced by high-frequency electric current to bring about local destruction of tissues |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CO2 Standard Cryotherapy- Double Freeze | Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue |
| BG001 | CO2 Standard Cryotherapy- Single Freeze |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Depth of Necrosis Achieved With the LMIC-adapted CryoPen and the Thermocoagulator Compared to Mean Depth of Necrosis Achieved With CO2-based Cryotherapy | Posted | Mean | Standard Deviation | millimeters | 24-48 hours after treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CO2 Standard Cryotherapy- Double Freeze | Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Miriam Cremer | Cleveland Clinic | 216-312-0618 | cremerm@ccf.org |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| OTHER |
| Albert Einstein College of Medicine | OTHER |
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| CO2 standard cryotherapy | Device | Standard therapy using carbon dioxide for freezing of tissue |
|
| Thermocoagulator | Device | The use of heat produced by high-frequency electric current to bring about local destruction of tissues |
|
| 40 seconds to 13 minutes |
| Lima |
| Peru |
Single freeze treatment consists of one five-minute freeze CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue |
| BG002 | CryoPen- Double Freeze | Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze CryoPen: Provides a means of freezing tissue without the use of gases or liquids |
| BG003 | CryoPen- Single Freeze | Single freeze treatment consists of one five-minute freeze CryoPen: Provides a means of freezing tissue without the use of gases or liquids |
| BG004 | Thermocoagulator | Single heat application at 100 ºC for 40 seconds Thermocoagulator: The use of heat produced by high-frequency electric current to bring about local destruction of tissues |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 |
| CryoPen- Double Freeze |
Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze CryoPen: Provides a means of freezing tissue without the use of gases or liquids |
| OG003 | CryoPen- Single Freeze | Single freeze treatment consists of one five-minute freeze CryoPen: Provides a means of freezing tissue without the use of gases or liquids |
| OG004 | Thermocoagulator | Single heat application at 100 ºC for 40 seconds Thermocoagulator: The use of heat produced by high-frequency electric current to bring about local destruction of tissues |
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | 40 seconds to 13 minutes |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | CO2 Standard Cryotherapy- Single Freeze | Single freeze treatment consists of one five-minute freeze CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | CryoPen- Double Freeze | Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze CryoPen: Provides a means of freezing tissue without the use of gases or liquids | 0 | 26 | 0 | 26 | 0 | 26 |
| EG003 | CryoPen- Single Freeze | Single freeze treatment consists of one five-minute freeze CryoPen: Provides a means of freezing tissue without the use of gases or liquids | 0 | 25 | 0 | 25 | 0 | 25 |
| EG004 | Thermocoagulator | Single heat application at 100 ºC for 40 seconds Thermocoagulator: The use of heat produced by high-frequency electric current to bring about local destruction of tissues | 0 | 28 | 0 | 28 | 0 | 28 |
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| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |