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An Innovative Treatment for Cervical Pre Cancer (CryoPen)

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ClinicalTrials.gov Identifier: NCT02814448
Recruitment Status : Completed
First Posted : June 27, 2016
Results First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Basic Health International
CryoPen, Inc.
University of Southern California
Albert Einstein College of Medicine
Information provided by (Responsible Party):
The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Cervical Intraepithelial Neoplasia
Interventions Device: CryoPen
Device: CO2 standard cryotherapy
Device: Thermocoagulator
Enrollment 130
Recruitment Details Participants were between the ages of 25 and 65 to be eligible for the study
Pre-assignment Details  
Arm/Group Title CO2 Standard Cryotherapy- Double Freeze CO2 Standard Cryotherapy- Single Freeze CryoPen- Double Freeze CryoPen- Single Freeze Thermocoagulator
Hide Arm/Group Description

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

Single freeze treatment consists of one five-minute freeze

CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue

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

Single freeze treatment consists of one five-minute freeze

CryoPen: Provides a means of freezing tissue without the use of gases or liquids

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

Period Title: Overall Study
Started 27 24 26 25 28
Completed 27 24 25 25 26
Not Completed 0 0 1 0 2
Arm/Group Title CO2 Standard Cryotherapy- Double Freeze CO2 Standard Cryotherapy- Single Freeze CryoPen- Double Freeze CryoPen- Single Freeze Thermocoagulator Total
Hide Arm/Group Description

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

Single freeze treatment consists of one five-minute freeze

CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue

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

Single freeze treatment consists of one five-minute freeze

CryoPen: Provides a means of freezing tissue without the use of gases or liquids

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

Total of all reporting groups
Overall Number of Baseline Participants 27 24 26 25 28 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 24 participants 26 participants 25 participants 28 participants 130 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
 100.0%
24
 100.0%
26
 100.0%
25
 100.0%
28
 100.0%
130
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 24 participants 26 participants 25 participants 28 participants 130 participants
45.46  (6.44) 45.5  (6.53) 45.92  (5.82) 44.65  (5.91) 45.35  (6.05) 45.37  (5.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 24 participants 26 participants 25 participants 28 participants 130 participants
Female
27
 100.0%
24
 100.0%
26
 100.0%
25
 100.0%
28
 100.0%
130
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 24 participants 26 participants 25 participants 28 participants 130 participants
El Salvador
15
  55.6%
15
  62.5%
16
  61.5%
15
  60.0%
18
  64.3%
79
  60.8%
Peru
12
  44.4%
9
  37.5%
10
  38.5%
10
  40.0%
10
  35.7%
51
  39.2%
1.Primary Outcome
Title Mean Depth of Necrosis Achieved With the LMIC-adapted CryoPen and the Thermocoagulator Compared to Mean Depth of Necrosis Achieved With CO2-based Cryotherapy
Hide Description [Not Specified]
Time Frame 24-48 hours after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CO2 Standard Cryotherapy- Double Freeze CO2 Standard Cryotherapy- Single Freeze CryoPen- Double Freeze CryoPen- Single Freeze Thermocoagulator
Hide Arm/Group Description:

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

Single freeze treatment consists of one five-minute freeze

CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue

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

Single freeze treatment consists of one five-minute freeze

CryoPen: Provides a means of freezing tissue without the use of gases or liquids

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

Overall Number of Participants Analyzed 27 24 25 25 26
Mean (Standard Deviation)
Unit of Measure: millimeters
6.0  (1.6) 5.6  (1.9) 5.3  (1.2) 5.5  (1.3) 3.5  (0.9)
2.Secondary Outcome
Title Mean Pain During Treatment Reported by Patients Treated With Double and Single Freeze CO2 Cryotherapy, Double and Single Freeze CryoPen and Thermoablation
Hide Description 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).
Time Frame 40 seconds to 13 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CO2 Standard Cryotherapy- Double Freeze CO2 Standard Cryotherapy- Single Freeze CryoPen- Double Freeze CryoPen- Single Freeze Thermocoagulator
Hide Arm/Group Description:

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

Single freeze treatment consists of one five-minute freeze

CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue

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

Single freeze treatment consists of one five-minute freeze

CryoPen: Provides a means of freezing tissue without the use of gases or liquids

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

Overall Number of Participants Analyzed 27 24 25 25 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.2  (1.0) 1.8  (0.8) 2.5  (1.4) 2.6  (1.4) 4.1  (2.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CO2 Standard Cryotherapy- Double Freeze CO2 Standard Cryotherapy- Single Freeze CryoPen- Double Freeze CryoPen- Single Freeze Thermocoagulator
Hide Arm/Group Description

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

Single freeze treatment consists of one five-minute freeze

CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue

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

Single freeze treatment consists of one five-minute freeze

CryoPen: Provides a means of freezing tissue without the use of gases or liquids

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

All-Cause Mortality
CO2 Standard Cryotherapy- Double Freeze CO2 Standard Cryotherapy- Single Freeze CryoPen- Double Freeze CryoPen- Single Freeze Thermocoagulator
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/24 (0.00%)   0/26 (0.00%)   0/25 (0.00%)   0/28 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
CO2 Standard Cryotherapy- Double Freeze CO2 Standard Cryotherapy- Single Freeze CryoPen- Double Freeze CryoPen- Single Freeze Thermocoagulator
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/24 (0.00%)   0/26 (0.00%)   0/25 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CO2 Standard Cryotherapy- Double Freeze CO2 Standard Cryotherapy- Single Freeze CryoPen- Double Freeze CryoPen- Single Freeze Thermocoagulator
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/24 (0.00%)   0/26 (0.00%)   0/25 (0.00%)   0/28 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Miriam Cremer
Organization: Cleveland Clinic
Phone: 216-312-0618
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02814448     History of Changes
Other Study ID Numbers: 15-296
UH2CA189883 ( U.S. NIH Grant/Contract )
First Submitted: June 13, 2016
First Posted: June 27, 2016
Results First Submitted: April 23, 2018
Results First Posted: November 20, 2018
Last Update Posted: November 20, 2018