Infections

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Warts

Communicable Diseases

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Virus Diseases

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

CellFX device using pre-defined energy protocols

Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.

The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.

CellFX System Device

Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.

Cryosurgery Liquid Nitrogen Sprayer

Richard Nuccitelli, PhD

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.

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.

CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts

A Multicenter, Prospective, Randomized, Comparison IDE Study Between the Pulse Biosciences CellFX System and Cryosurgery for the Treatment of Cutaneous Non-Genital Common Warts

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 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 skin change safety event is defined as the presence of hyperpigmentation, hypopigmentation, or scarring as assessed by the blinded site investigator.

Pulse Biosciences, Inc.

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.

CellFX 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.

Cryosurgical Procedure

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Total number of enrolled warts per treatment

William A. Knape, VP Clinical, Regulatory, and Quality Affairs

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.

Percentage of Warts Resolved

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.

Percentage of Warts Treated With Skin Textural Changes

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts	NCT04738734	Warts Warts Hand Verruca	CellFX System D... Cryosurgery Liq...	22 Years - 80 Years	Pulse Biosciences, Inc.
CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts	NCT04738734	Warts Warts Hand Verruca	CellFX System D... Cryosurgery Liq...	22 Years - 80 Years	Pulse Biosciences, Inc.

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