Trial Outcomes & Findings for An Innovative Treatment for Cervical Pre Cancer (NCT NCT02814448)

NCT ID: NCT02814448

Last Updated: 2018-11-20

Results Overview

Recruitment status

COMPLETED

Study phase

Target enrollment

130 participants

Primary outcome timeframe

24-48 hours after treatment

Results posted on

2018-11-20

Participant Flow

Participants were between the ages of 25 and 65 to be eligible for the study

Participant milestones

Participant milestones
Measure	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	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	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	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	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
Overall Study STARTED	27	24	26	25	28
Overall Study COMPLETED	27	24	25	25	26
Overall Study NOT COMPLETED	0	0	1	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Innovative Treatment for Cervical Pre Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CO2 Standard Cryotherapy- Double Freeze n=27 Participants 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	CO2 Standard Cryotherapy- Single Freeze n=24 Participants Single freeze treatment consists of one five-minute freeze CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue	CryoPen- Double Freeze n=26 Participants 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	CryoPen- Single Freeze n=25 Participants Single freeze treatment consists of one five-minute freeze CryoPen: Provides a means of freezing tissue without the use of gases or liquids	Thermocoagulator n=28 Participants 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 n=130 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	24 Participants n=7 Participants	26 Participants n=5 Participants	25 Participants n=4 Participants	28 Participants n=21 Participants	130 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Continuous	45.46 years STANDARD_DEVIATION 6.44 • n=5 Participants	45.5 years STANDARD_DEVIATION 6.53 • n=7 Participants	45.92 years STANDARD_DEVIATION 5.82 • n=5 Participants	44.65 years STANDARD_DEVIATION 5.91 • n=4 Participants	45.35 years STANDARD_DEVIATION 6.05 • n=21 Participants	45.37 years STANDARD_DEVIATION 5.98 • n=10 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	24 Participants n=7 Participants	26 Participants n=5 Participants	25 Participants n=4 Participants	28 Participants n=21 Participants	130 Participants n=10 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Region of Enrollment El Salvador	15 Participants n=5 Participants	15 Participants n=7 Participants	16 Participants n=5 Participants	15 Participants n=4 Participants	18 Participants n=21 Participants	79 Participants n=10 Participants
Region of Enrollment Peru	12 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	51 Participants n=10 Participants

PRIMARY outcome

Timeframe: 24-48 hours after treatment

Outcome measures

Outcome measures
Measure	CO2 Standard Cryotherapy- Double Freeze n=27 Participants 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	CO2 Standard Cryotherapy- Single Freeze n=24 Participants Single freeze treatment consists of one five-minute freeze CO2 standard cryotherapy: Standard therapy using carbon dioxide for freezing of tissue	CryoPen- Double Freeze n=25 Participants 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	CryoPen- Single Freeze n=25 Participants Single freeze treatment consists of one five-minute freeze CryoPen: Provides a means of freezing tissue without the use of gases or liquids	Thermocoagulator n=26 Participants 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
Mean Depth of Necrosis Achieved With the LMIC-adapted CryoPen and the Thermocoagulator Compared to Mean Depth of Necrosis Achieved With CO2-based Cryotherapy	6.0 millimeters Standard Deviation 1.6	5.6 millimeters Standard Deviation 1.9	5.3 millimeters Standard Deviation 1.2	5.5 millimeters Standard Deviation 1.3	3.5 millimeters Standard Deviation 0.9

SECONDARY outcome

Timeframe: 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).