Trial Outcomes & Findings for An Innovative Treatment for Cervical Precancer (UH3) (NCT NCT03084081)

NCT ID: NCT03084081

Last Updated: 2025-04-06

Results Overview

Diagnosis of recurrent and or untreated cervical intraepithelial neoplasia grade 2 or higher with cervical cancer diagnosis

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1132 participants
• Primary outcome timeframe: 12-months post treatment
• Results posted on: 2025-04-06

Participant Flow

Participant milestones

Measure	CO2 Standard Therapy Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze CO2 standard therapy: Standard therapy using carbon dioxide for freezing of tissue	CryoPen Single freeze treatment consists of one five-minute freeze CryoPen: Provides a means of freezing tissue without the use of gases or liquids	Thermocoagulator Thermal ablation for 40-seconds at 100 degrees Celsius and reapplied at 20 second applications to cover the entire transformation zone. Thermocoagulator: Thermoablation
Overall Study STARTED	377	377	378
Overall Study COMPLETED	332	332	344
Overall Study NOT COMPLETED	45	45	34

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Innovative Treatment for Cervical Precancer (UH3)

Baseline characteristics by cohort

Measure	CO2 Standard Therapy n=377 Participants Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze CO2 standard therapy: Standard therapy using carbon dioxide for freezing of tissue	CryoPen n=377 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=378 Participants Thermoablation for 60-seconds at 100 degrees Celsius Thermocoagulator: Thermoablation	Total n=1132 Participants Total of all reporting groups
Age, Customized Mean age in years	36.3 years STANDARD_DEVIATION 9.6 • n=5 Participants	36.9 years STANDARD_DEVIATION 9.0 • n=7 Participants	35.9 years STANDARD_DEVIATION 8.9 • n=5 Participants	36.4 years STANDARD_DEVIATION 9.2 • n=4 Participants
Sex: Female, Male Female	377 Participants n=5 Participants	377 Participants n=7 Participants	378 Participants n=5 Participants	1132 Participants n=4 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
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	256 Participants n=5 Participants	256 Participants n=7 Participants	257 Participants n=5 Participants	769 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	121 Participants n=5 Participants	121 Participants n=7 Participants	121 Participants n=5 Participants	363 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Colombia	31 participants n=5 Participants	31 participants n=7 Participants	31 participants n=5 Participants	93 participants n=4 Participants
Region of Enrollment El Salvador	90 participants n=5 Participants	90 participants n=7 Participants	90 participants n=5 Participants	270 participants n=4 Participants
Region of Enrollment China	256 participants n=5 Participants	256 participants n=7 Participants	257 participants n=5 Participants	769 participants n=4 Participants

PRIMARY outcome

Timeframe: 12-months post treatment

Diagnosis of recurrent and or untreated cervical intraepithelial neoplasia grade 2 or higher with cervical cancer diagnosis

Outcome measures

Measure	CO2 Standard Therapy n=377 Participants Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze CO2 standard therapy: Standard therapy using carbon dioxide for freezing of tissue	CryoPen n=377 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=378 Participants Thermal ablation for 40-seconds at 100 degrees Celsius and reapplied at 20 second applications to cover the entire transformation zone. Thermocoagulator: Thermoablation
Proportion of Participants With Residual CIN2+	18 Participants	29 Participants	25 Participants

SECONDARY outcome

Timeframe: Pain during treatment

Patient pain scores using the Wong-Baker FACES Pain Rating Scale from 0-10 where 0 represents the best outcome (no pain) and 10 represents the worst outcome (worst pain). The underlying construct is pain experienced by the participant.

Outcome measures

Measure	CO2 Standard Therapy n=377 Participants Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze CO2 standard therapy: Standard therapy using carbon dioxide for freezing of tissue	CryoPen n=377 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=378 Participants Thermal ablation for 40-seconds at 100 degrees Celsius and reapplied at 20 second applications to cover the entire transformation zone. Thermocoagulator: Thermoablation
Self-reported Pain	2 units on a scale Interval 0.0 to 4.0	2 units on a scale Interval 0.0 to 4.0	4 units on a scale Interval 2.0 to 6.0

Adverse Events

CO2 Standard Therapy

Serious events: 1 serious events

Other events: 167 other events

Deaths: 0 deaths

CryoPen

Serious events: 0 serious events

Other events: 143 other events

Deaths: 0 deaths

Thermocoagulator

Serious events: 0 serious events

Other events: 64 other events

Deaths: 0 deaths

Serious adverse events

Measure	CO2 Standard Therapy n=377 participants at risk Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze CO2 standard therapy: Standard therapy using carbon dioxide for freezing of tissue	CryoPen n=377 participants at risk 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=378 participants at risk Thermal ablation for 40-seconds at 100 degrees Celsius and reapplied at 20 second applications to cover the entire transformation zone. Thermocoagulator: Thermoablation
Infections and infestations Hospitalization	0.27% 1/377 • Number of events 1 • 12 months	0.00% 0/377 • 12 months	0.00% 0/378 • 12 months

Other adverse events

Measure	CO2 Standard Therapy n=377 participants at risk Double freeze treatment consists of three-minute freeze, five-minute thaw, three-minute freeze CO2 standard therapy: Standard therapy using carbon dioxide for freezing of tissue	CryoPen n=377 participants at risk 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=378 participants at risk Thermal ablation for 40-seconds at 100 degrees Celsius and reapplied at 20 second applications to cover the entire transformation zone. Thermocoagulator: Thermoablation
Nervous system disorders Vasovagal response	36.6% 138/377 • Number of events 138 • 12 months	32.1% 121/377 • Number of events 121 • 12 months	6.3% 24/378 • Number of events 24 • 12 months
Infections and infestations Infection	7.7% 29/377 • Number of events 29 • 12 months	5.8% 22/377 • Number of events 22 • 12 months	10.6% 40/378 • Number of events 40 • 12 months

Additional Information

Miriam Cremer, M.D.

Cleveland Clinic

Phone: 216-213-6460

Email: cremerm@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place