Trial Outcomes & Findings for CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts (NCT NCT04738734)
NCT ID: NCT04738734
Last Updated: 2023-11-24
Results Overview
The primary effectiveness endpoint is the percentage of warts resolved or cleared as assessed "live" by the blinded site investigator at 30 days after the last treatment with CellFX or Cryosurgical Procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
30 days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months
Results posted on
2023-11-24
Participant Flow
Participant milestones
| Measure |
CellFX Procedure
CellFX device using pre-defined energy protocols
CellFX System Device: The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.
|
Cryosurgical Procedure
Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.
Cryosurgery Liquid Nitrogen Sprayer: Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
75
|
|
Overall Study
COMPLETED
|
68
|
67
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
CellFX Procedure
CellFX device using pre-defined energy protocols
CellFX System Device: The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.
|
Cryosurgical Procedure
Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.
Cryosurgery Liquid Nitrogen Sprayer: Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Lost to Follow-up
|
5
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Mistake of termination of subject by clinical site
|
0
|
1
|
Baseline Characteristics
CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts
Baseline characteristics by cohort
| Measure |
CellFX Procedure
n=75 Participants
CellFX device using pre-defined energy protocols
CellFX System Device: The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.
|
Cryosurgical Procedure
n=75 Participants
Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.
Cryosurgery Liquid Nitrogen Sprayer: Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.6 Years
n=5 Participants
|
46.2 Years
n=7 Participants
|
45.4 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Warts
|
231 warts
n=5 Participants
|
248 warts
n=7 Participants
|
479 warts
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 monthsPopulation: The population consisted of participants with treated warts and evaluated at 30-days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months.
The primary effectiveness endpoint is the percentage of warts resolved or cleared as assessed "live" by the blinded site investigator at 30 days after the last treatment with CellFX or Cryosurgical Procedure.
Outcome measures
| Measure |
CellFX Procedure
n=216 wart lesions
CellFX device using pre-defined energy protocols
CellFX System Device: The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.
|
Cryosurgical Procedure
n=232 wart lesions
Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.
Cryosurgery Liquid Nitrogen Sprayer: Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.
|
|---|---|---|
|
Percentage of Warts Resolved
|
80.7 percentage of warts resolved
Interval 71.1 to 90.2
|
73.1 percentage of warts resolved
Interval 64.2 to 81.9
|
PRIMARY outcome
Timeframe: 30 days from the last CellFX or Cryosurgical Procedure up to a maximum of 3 monthsPopulation: The population consisted of participants with treated warts and evaluated for skin textural changes at 30-days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months.
The safety endpoint is the percentage of warts with skin textural changes where the wart was originally treated and showed textual changes of the surrounding skin where the wart was treated and included; scabbing, swelling, crusting, blister, or ulceration when assessed by the blinded site investigator.
Outcome measures
| Measure |
CellFX Procedure
n=216 wart lesions
CellFX device using pre-defined energy protocols
CellFX System Device: The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.
|
Cryosurgical Procedure
n=232 wart lesions
Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.
Cryosurgery Liquid Nitrogen Sprayer: Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.
|
|---|---|---|
|
Percentage of Warts Treated With Skin Textural Changes
|
41.4 percentage of warts
Interval 32.5 to 50.3
|
13.1 percentage of warts
Interval 5.73 to 20.5
|
PRIMARY outcome
Timeframe: 90 days from the last CellFX or Cryosurgical Procedure up to a maximum of 6 monthsPopulation: The population consisted of participants with treated warts and evaluated at 90-days following the last CellFX or Cryosurgical Procedure up to a maximum of 6 months.
The skin change safety event is defined as the presence of hyperpigmentation, hypopigmentation, or scarring as assessed by the blinded site investigator.
Outcome measures
| Measure |
CellFX Procedure
n=208 wart lesions
CellFX device using pre-defined energy protocols
CellFX System Device: The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.
|
Cryosurgical Procedure
n=227 wart lesions
Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.
Cryosurgery Liquid Nitrogen Sprayer: Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.
|
|---|---|---|
|
Presence of Pigmentary and Scarring Skin Changes
|
37.3 percentage of lesions
Interval 25.5 to 49.0
|
23.7 percentage of lesions
Interval 14.1 to 33.3
|
Adverse Events
CellFX Procedure
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cryosurgical Procedure
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CellFX Procedure
n=75 participants at risk
CellFX device using pre-defined energy protocols
CellFX System Device: The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.
|
Cryosurgical Procedure
n=75 participants at risk
Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.
Cryosurgery Liquid Nitrogen Sprayer: Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Neoplasm
|
1.3%
1/75 • Number of events 1 • 150 days
|
1.3%
1/75 • Number of events 3 • 150 days
|
|
Skin and subcutaneous tissue disorders
Neoplasm of uncertain behavior of skin
|
0.00%
0/75 • 150 days
|
1.3%
1/75 • Number of events 1 • 150 days
|
|
Skin and subcutaneous tissue disorders
Paraesthesia
|
4.0%
3/75 • Number of events 5 • 150 days
|
0.00%
0/75 • 150 days
|
|
Skin and subcutaneous tissue disorders
Neuropathy
|
2.7%
2/75 • Number of events 2 • 150 days
|
0.00%
0/75 • 150 days
|
|
Skin and subcutaneous tissue disorders
Infection
|
1.3%
1/75 • Number of events 1 • 150 days
|
0.00%
0/75 • 150 days
|
|
Infections and infestations
Tinea Versicolor
|
1.3%
1/75 • Number of events 1 • 150 days
|
0.00%
0/75 • 150 days
|
|
General disorders
Pain
|
2.7%
2/75 • Number of events 2 • 150 days
|
0.00%
0/75 • 150 days
|
Additional Information
William A. Knape, VP Clinical, Regulatory, and Quality Affairs
Pulse Biosciences, Inc.
Phone: 510-906-4649
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60