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This prospective, multicenter, single-blinded, randomized comparison study is designed to compare the safety and effectiveness of the CellFX System to Cryosurgery for the clearance of cutaneous non-genital common warts on all areas of the body excluding the scalp, nose, within the orbital region of the face, plantar or periungual area in healthy adult subjects.
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. Macrophotography of all study warts will be captured along with a blinded site Investigator to characterize wart healing, wart clearance and wart reduction. All subjects will be followed at 7, 30, 60, and 90-days following the last CellFX or Cryosurgical Procedure. All wart lesions are eligible for up to a total of 3 treatments over the course of the study. Adverse events will be documented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CellFX Procedure | Experimental | CellFX device using pre-defined energy protocols |
|
| Cryosurgical Procedure | Active Comparator | Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CellFX System 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 Warts Resolved | 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. | 30 days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months |
| Percentage of Warts Treated With Skin Textural Changes | 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. | 30 days from the last CellFX or Cryosurgical Procedure up to a maximum of 3 months |
| Presence of Pigmentary and Scarring Skin Changes | The skin change safety event is defined as the presence of hyperpigmentation, hypopigmentation, or scarring as assessed by the blinded site investigator. | 90 days from the last CellFX or Cryosurgical Procedure up to a maximum of 6 months |
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Inclusion Criteria:
topical medication including over-the-counter medications) during the study period.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Nuccitelli, PhD | Pulse Biosciences, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigate MD | Scottsdale | Arizona | 85255 | United States | ||
| Moy-Fincher-Chipps Dermatology |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Cryosurgical Procedure |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2021 |
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Each subject will be evaluated by the blinded site investigator conducting assessment of outcomes at 7, 30, 60, and 90-days following CellFX and Cryosurgical treatments.
| Cryosurgery Liquid Nitrogen Sprayer | Device | Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe. |
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| Beverly Hills |
| California |
| 90210 |
| United States |
| AboutSkin Dermatology and DermSurgery | Greenwood Village | Colorado | 80111 | United States |
| Palm Harbor Dermatology | Clearwater | Florida | 34685 | United States |
| Oak Dermatology | Joliet | Illinois | 60435 | United States |
| Juva Skin & Laser Center | New York | New York | 10022 | United States |
| Dermatology, Laser & Vein Specialists of the Carolinas | Charlotte | North Carolina | 28207 | United States |
| Dermatology & Laser Center of Charleston | Charleston | South Carolina | 29414 | United States |
| Austin Institute for Clinical Research, Inc. | Houston | Texas | 77056 | United States |
| Austin Institute for Clinical Research, Inc. | Pflugerville | Texas | 78550 | United States |
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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Warts | Total number of enrolled warts per treatment | Number | warts |
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| 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 Warts Resolved | 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. | 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. | Posted | Mean | 95% Confidence Interval | percentage of warts resolved | 30 days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months | wart lesions | wart lesions |
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| Primary | Percentage of Warts Treated With Skin Textural Changes | 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. | 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. | Posted | Mean | 95% Confidence Interval | percentage of warts | 30 days from the last CellFX or Cryosurgical Procedure up to a maximum of 3 months | wart lesions | wart lesions |
| ||||||||||||||||||||||||||||||
| Primary | Presence of Pigmentary and Scarring Skin Changes | The skin change safety event is defined as the presence of hyperpigmentation, hypopigmentation, or scarring as assessed by the blinded site investigator. | 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. | Posted | Mean | 95% Confidence Interval | percentage of lesions | 90 days from the last CellFX or Cryosurgical Procedure up to a maximum of 6 months | wart lesions | wart lesions |
|
|
150 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 75 | 0 | 75 | 10 | 75 |
| EG001 | 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. | 0 | 75 | 0 | 75 | 2 | 75 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Neoplasm | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment | Presence of non-melanoma skin cancer (SCC) was at the site of the treated lesion along with an Actinic Keratotic lesion treated with Cryotherapy. One participant showed a BCC lesion not related to treatment site. |
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| Neoplasm of uncertain behavior of skin | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment | Biopsy showed wart |
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| Paraesthesia | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment | Numbness or altered sensation at the site of treatment |
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| Neuropathy | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment | Sensory disturbance including numbness or altered sensation and resolved within 2-6 days |
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| Infection | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment | Suspect Skin Infection, no culture collected |
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| Tinea Versicolor | Infections and infestations | MedDRA 10.0 | Systematic Assessment | Participant has recurrent fungal infections that usually have resolved within 2 months. |
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| Pain | General disorders | MedDRA 10.0 | Systematic Assessment | Post-procedure pain for one participant that resolved less than 24 hours. Second participant had persistent pain post treatment that resolved within 5 months without intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William A. Knape, VP Clinical, Regulatory, and Quality Affairs | Pulse Biosciences, Inc. | 510-906-4649 | bknape@pulsebiosciences.com |
| Jul 20, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014860 | Warts |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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| wart lesions |
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| Counts |
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| Participants |
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| wart lesions |
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