Infections

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Warts

Communicable Diseases

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

Treated wart with CellFX device intervention

Control wart for each enrolled subject without intervention

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 Device

Richard Nuccitelli, PhD

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.

CellFX System for the Treatment of Cutaneous Non-Genital Warts

A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation™ (NPS™) Treatment of Cutaneous Non-Genital Warts

Percentage of Verrucae with Clearance (91-100% reduction)

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)

Pulse Biosciences, Inc.

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.

CellFX Treated Wart Lesion

CellFX Treated Verrucae

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Class I

Class II

Class III

Class IV

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.

Fitzpatrick Skin Type

Treated

Control

Not treated

Verrucae Disposition

Common

Plantar

Flat

Wart Subtype

Hand

Foot

Knee

Ankle

Elbow

Wrist

Torso

Anatomic Location

Cryotherapy

Over the Counter Medical Treatment

Laser Treatment

Over the Counter and Laser Treatment

Electrocautery

Cantharone and Cryotherapy

Investigational Product

Aldara and Cryotherapy

Laser Treatment and Cryotherapy

Yeast Injection

History of Prior Verrucae Treatment

Subjects diagnosed with cutaneous warts, including common, flat and plantar subgroups

William A. Knape

Warts Treated With CellFX (Common, Flat, and Plantar)

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CellFX System for the Treatment of Cutaneous Non-Genital Warts	NCT04554394	Warts Warts Hand Verruca	CellFX Device	21 Years - 80 Years	Pulse Biosciences, Inc.
CellFX System for the Treatment of Cutaneous Non-Genital Warts	NCT04554394	Warts Warts Hand Verruca	CellFX Device	21 Years - 80 Years	Pulse Biosciences, Inc.

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