Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CellFX Treated Wart | Experimental | Treated wart with CellFX device intervention |
|
| Non-treated Wart | No Intervention | Control wart for each enrolled subject without intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CellFX Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Verrucae Cleared | Percentage of Verrucae with Clearance (91-100% reduction) | 60-days post-last CellFX treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 60-days post-last CellFX treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard Nuccitelli, PhD | Pulse Biosciences, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigate MD, LLC | Scottsdale | Arizona | 85255 | United States | ||
| Scripps Clinic Carmel Valley |
Not provided
Not provided
Not provided
Not provided
Not provided
62 subjects were enrolled. One wart per subject was randomized and pre-assigned as the control.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | CellFX Treated Warts | 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. |
| FG001 | Non-Treated Controls | Non-treated wart arm, one study wart per enrolled subject. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects diagnosed with cutaneous warts, including common, flat and plantar subgroups
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Verrucae Cleared | Percentage of Verrucae with Clearance (91-100% reduction) | 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. | Posted | Number | percentage of verrucae clearance | 60-days post-last CellFX treatment | common verrucae | common verrucae |
|
4 months after initial CellFX Treatment
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CellFX Treated Wart Lesion | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral Sensory Neuropathy | Nervous system disorders | Systematic Assessment | Transient Numbness at the Target Site resolving without medical intervention. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William A. Knape | Pulse Biosciences, Inc. | (919) 757-2033 | bill.knape@pulsebiosciences.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 4, 2019 | May 30, 2021 | Prot_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014860 | Warts |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| San Diego |
| California |
| 92130 |
| United States |
| Skin Search of Rochester, Inc. | Rochester | New York | 14623 | United States |
| Dermatology, Laser & Vein Specialists of the Carolinas, PLLC | Charlotte | North Carolina | 28207 | United States |
| Austin Institute for Clinical Research, Inc. | Pflugerville | Texas | 78550 | United States |
| Lost to Follow-up |
|
| Physician Decision |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Fitzpatrick Skin Type | The Fitzpatrick skin phototypes (FSP) were developed in Boston in 1975 for use with phototherapy. The scale's original purpose was to help determine a patient's risk of burning or tanning when exposed to UV light. The current scale classifies skin from types I to VI. Type I refers to skin that always burns, while type VI refers to skin that never burns. In general, a lower FSP means a person's skin burns more easily than it tans. A higher FSP means that a person's skin does not burn easily. | Count of Participants | Participants |
|
| Verrucae Disposition | Number | warts |
|
| Wart Subtype | Subtype of wart treated in the study | Number | warts |
|
| Anatomic Location | Location of wart lesion | Number | warts |
|
| History of Prior Verrucae Treatment | Number | warts |
|
| Units | Counts |
|---|
| Participants |
|
| common verrucae |
|
|
| 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) | All Treated Verrucae observed at 60-days post-last CellFX treatment | Posted | Number | percentage of participants | 60-days post-last CellFX treatment | total treated warts | total treated warts |
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| 8 |
| 62 |
|
| Pain | General disorders | Systematic Assessment | Pain at Treatment Site treated with Motrin. |
|
| Infection | Infections and infestations | Systematic Assessment | Suspect infection. Neosporin used in one subject and antibiotic used in second subject with both events resolving within 2 weeks. No cultures performed for both subjects. Third subject had a negative culture and event resolved within 5 days. |
|
| Numbness and swelling | General disorders | Systematic Assessment | Numbness and swelling reported at the index finger of right hand and took Motrin as needed with resolution of event by 1-month. |
|
Not provided
| D017193 |
| Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |