Verruca, Warts, Warts Hand
Conditions
Keywords
CellFX, Nano-Pulse Stimulation, NPS, Clearance
Brief summary
This prospective, non-randomized, multicenter pivotal study is designed to evaluate the safety and effectiveness of the CellFX System in patients with cutaneous non-genital warts on all areas of the body, excluding the face.
Detailed description
The study will enroll healthy adult subjects with a minimum of two cutaneous non-genital warts, excluding the face, with each wart lesion not exceeding 10 x 10mm. One of the warts for each subject will be untreated and will serve as the subject's internal control. Macrophotography of all study warts will be captured along with Investigator assessments using the Wart Measurement Scale (WMS) and lesion measurements for wart reduction. All subjects will be followed at 7, 30, 60, 90 and 120-days post-initial CellFX treatment. All wart lesions are eligible for re-treatment up to 3 times over the course of the study. Adverse events will be documented.
Interventions
DEVICECellFX 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.
Sponsors
Pulse Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must be at least 21 and not older than 80 years of age * Subjects must be able to read and speak English or Spanish * Subjects must sign a written informed consent to participate in the study, prior to any study related procedures * Subject must have a minimum of two cutaneous non-genital warts, each not exceeding 10 x 10mm * Subject is willing to undergo all study-mandated procedures * Subject agrees to refrain from using all other wart removal products or treatments (topical medication including over-the-counter medications) during the study period
Exclusion criteria
* Subject has an implantable electronic medical device. (pacemaker, implantable cardioverter defibrillator, etc.) * Subject has cochlear implants * Subject has an active systemic infection or history of an infection in the designated treatment area within 90 days of enrollment * Subject has a history of and/or current tinnitus * Subject is known to be immune-compromised * Subject is taking a blood thinning medication (Antiplatelet, Anticoagulation, Factor Xa Inhibitor, etc.) * Subject has Type 1 Diabetes and is insulin dependent * Subject has a known allergy to Lidocaine or Lidocaine-like products * Subject is a member of a vulnerable population including individuals employed by the Sponsor, clinic site, or entity associated with the conduct of the study * Subject has a comorbidity or condition which may reduce compliance with this protocol, including follow-up visits * Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Verrucae Cleared | 60-days post-last CellFX treatment | Percentage of Verrucae with Clearance (91-100% reduction) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | 60-days post-last CellFX treatment | Satisfaction with reduction in verrucae size or clearance of verrucae measured using the following scale; 5 (Satisfied), 4 (Mostly Satisfied), 3 (Partially Satisfied), 2 (Dissatisfied), 1 (Highly Dissatisfied) |
Countries
United States
Participant flow
Recruitment details
A total of 62 study subjects were enrolled. A total of 257 warts were studied, including 195 warts assigned to treatment and 62 assigned to control arm.
Pre-assignment details
62 subjects were enrolled. One wart per subject was randomized and pre-assigned as the control.
Participants by arm
| Arm | Count |
|---|---|
| CellFX Treated Verrucae CellFX device using pre-defined energy protocols
CellFX 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. | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Clinical Site Closed due to COVID-19 Restrictions | 4 | 4 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | CellFX Treated Verrucae |
|---|---|
| Age, Continuous | 47.3 Years STANDARD_DEVIATION 15.4 |
| Anatomic Location Ankle | 6 warts |
| Anatomic Location Arm | 4 warts |
| Anatomic Location Elbow | 3 warts |
| Anatomic Location Foot | 79 warts |
| Anatomic Location Hand | 131 warts |
| Anatomic Location Knee | 10 warts |
| Anatomic Location Leg | 23 warts |
| Anatomic Location Torso | 2 warts |
| Anatomic Location Wrist | 3 warts |
| Fitzpatrick Skin Type Class I | 3 Participants |
| Fitzpatrick Skin Type Class II | 27 Participants |
| Fitzpatrick Skin Type Class III | 20 Participants |
| Fitzpatrick Skin Type Class IV | 12 Participants |
| History of Prior Verrucae Treatment Aldara and Cryotherapy | 1 warts |
| History of Prior Verrucae Treatment Cantharone and Cryotherapy | 4 warts |
| History of Prior Verrucae Treatment Cryotherapy | 49 warts |
| History of Prior Verrucae Treatment Electrocautery | 7 warts |
| History of Prior Verrucae Treatment Investigational Product | 2 warts |
| History of Prior Verrucae Treatment Laser Treatment | 10 warts |
| History of Prior Verrucae Treatment Laser Treatment and Cryotherapy | 1 warts |
| History of Prior Verrucae Treatment Over the Counter and Laser Treatment | 8 warts |
| History of Prior Verrucae Treatment Over the Counter Medical Treatment | 40 warts |
| History of Prior Verrucae Treatment Yeast Injection | 1 warts |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 58 Participants |
| Region of Enrollment United States | 62 Participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 20 Participants |
| Verrucae Disposition Control | 62 warts |
| Verrucae Disposition Not treated | 10 warts |
| Verrucae Disposition Treated | 195 warts |
| Wart Subtype Common | 195 warts |
| Wart Subtype Flat | 17 warts |
| Wart Subtype Plantar | 55 warts |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 62 |
| other Total, other adverse events | 8 / 62 |
| serious Total, serious adverse events | 0 / 62 |
Outcome results
Primary
Percentage of Verrucae Cleared
Percentage of Verrucae with Clearance (91-100% reduction)
Time frame: 60-days post-last CellFX treatment
Population: Percent of verrucae clearance observed at 60-days post-last treatment. Reduction in verrucae size and/or clearance not assessed in the Non-treated Control Arm/Group or similar.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Warts Treated With CellFX (Common, Flat, and Plantar) | Percentage of Verrucae Cleared | 67.6 percentage of verrucae clearance |
Secondary
Subject Satisfaction
Satisfaction with reduction in verrucae size or clearance of verrucae measured using the following scale; 5 (Satisfied), 4 (Mostly Satisfied), 3 (Partially Satisfied), 2 (Dissatisfied), 1 (Highly Dissatisfied)
Time frame: 60-days post-last CellFX treatment
Population: All Treated Verrucae observed at 60-days post-last CellFX treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Warts Treated With CellFX (Common, Flat, and Plantar) | Subject Satisfaction | 73.7 percentage of participants |