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

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.

Study Overview

• Status: Completed
• Conditions: Warts; Warts Hand; Verruca
• Intervention / Treatment: Device: CellFX Device

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Investigate MD, LLC
  • California
    • San Diego, California, United States, 92130
      • Scripps Clinic Carmel Valley
  • New York
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester, Inc.
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
  • Texas
    • Pflugerville, Texas, United States, 78550
      • Austin Institute for Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects must be at least 21 and not older than 80 years of age
• Subjects must be able to read and speak English or Spanish
• Subjects must sign a written informed consent to participate in the study, prior to any study related procedures
• Subject must have a minimum of two cutaneous non-genital warts, each not exceeding 10 x 10mm
• Subject is willing to undergo all study-mandated procedures
• Subject agrees to refrain from using all other wart removal products or treatments (topical medication including over-the-counter medications) during the study period

Exclusion Criteria:

• Subject has an implantable electronic medical device. (pacemaker, implantable cardioverter defibrillator, etc.)
• Subject has cochlear implants
• Subject has an active systemic infection or history of an infection in the designated treatment area within 90 days of enrollment
• Subject has a history of and/or current tinnitus
• Subject is known to be immune-compromised
• Subject is taking a blood thinning medication (Antiplatelet, Anticoagulation, Factor Xa Inhibitor, etc.)
• Subject has Type 1 Diabetes and is insulin dependent
• Subject has a known allergy to Lidocaine or Lidocaine-like products
• Subject is a member of a vulnerable population including individuals employed by the Sponsor, clinic site, or entity associated with the conduct of the study
• Subject has a comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
• Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CellFX Treated Wart; Treated wart with CellFX device intervention	Device: 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.
No Intervention: Non-treated Wart; Control wart for each enrolled subject without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Verrucae Cleared	Percentage of Verrucae with Clearance (91-100% reduction)	60-days post-last CellFX treatment

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Pulse Biosciences, Inc.
• Investigators: Study Chair: Richard Nuccitelli, PhD, Pulse Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2019
• Primary Completion (Actual): June 9, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: August 29, 2020
• First Submitted That Met QC Criteria: September 12, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Clearance; NPS; CellFX; Nano-Pulse Stimulation
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Papillomavirus Infections; Skin Diseases, Viral; Tumor Virus Infections; Warts
• Other Study ID Numbers: NP-WP-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes