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.

Percentage of Verrucae Cleared

All Treated Verrucae observed at 60-days post-last CellFX treatment

Subject Satisfaction

CellFX Treated Warts

Non-treated wart arm, one study wart per enrolled subject.

Non-Treated Controls

Overall Study

Neoplasms

Carcinoma

Carcinoma, Basal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

CellFX System

Richard A. Nuccitelli, PhD

This prospective, multicenter, study is designed to evaluate the safety and effectiveness of the CellFX System in adults subjects with low-risk basal cell carcinoma (superficial and nodular) for complete histological clearance of the target lesion followed by surgical tumor excision 60 days post-treatment.

The study will enroll healthy adult subjects with confirmed low-risk (superficial and nodular) BCC lesion(s) by biopsy, excluding BCCs located on the face, neck, scalp, axilla, hands, feet, and genitals not exceeding 1.5 cm. Macrophotography of all study BCCs will be captured and clinically assessed by the site investigator for characterization of healing and scar appearance prior to and post-surgical excision. All subjects will be followed at 3, 7, 14, 30 and 60-days post-CellFX procedure and at 14, 30 and 60-days post-excision. Adverse events will be documented.

CellFX Treat & Resect Low-Risk BCC Feasibility Study

A Multicenter, Prospective, Treat and Resect Feasibility Study of the CellFX System for the Treatment of Low-Risk Basal Cell Carcinoma (BCC) Lesions

The primary effectiveness endpoint is the total number of lesions with complete histological clearance of the BCC lesion during histological review of microscopic analysis using H \& E slides. Counts and proportions will be assessed.

No serious adverse events related to CellFX Treatment or Procedure

Treatment of the BCC with CellFX System

CellFX System: Nano-Pulse Stimulation (NPS)

CellFX Procedure

Ethnicity (NIH/OMB)

Histological presence of superficial or nodular BCC

The total number of enrolled subjects in this study was 30 participants with 37 lesions.

William Knape / VP, Clinical, Regulatory and Quality Affairs

Number of Lesions With BCC Histological Clearance

Number of Participants With Treatment Related Serious Adverse Events

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.

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

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.

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.

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

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
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 Treat & Resect Low-Risk BCC Feasibility Study	NCT04918381	BCC - Basal Cel... BCC Excision Margin	CellFX System	22 Years - 85 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.
CellFX Treat & Resect Low-Risk BCC Feasibility Study	NCT04918381	BCC - Basal Cel... BCC Excision Margin	CellFX System	22 Years - 85 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.
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.

Spots Global Cancer Trial Database for cellfx

Every month we try and update this database with for cellfx cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cellfx

Every month we try and update this database with for cellfx cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cellfx cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.