CellFX System for the Treatment of Cutaneous Non-Genital Warts

NCT04554394 | Completed Results FDA Device

• 1 other identifier: NP-WP-010
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Warts; Warts Hand; Verruca

Keywords

CellFX; Nano-Pulse Stimulation; NPS; Clearance

Outcome Measures

Primary Outcomes (1)

• Percentage of Verrucae Cleared

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

  60-days post-last CellFX treatment

Secondary Outcomes (1)

• Subject Satisfaction

  60-days post-last CellFX treatment

Study Arms (2)

CellFX Treated Wart

EXPERIMENTAL

Treated wart with CellFX device intervention

Device: CellFX Device

Non-treated Wart

NO INTERVENTION

Control wart for each enrolled subject without intervention

Interventions

CellFX 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.

CellFX Treated Wart

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pulse Biosciences, Inc.: lead

Study Sites (5)

Investigate MD, LLC

Scottsdale, Arizona, 85255, United States

Location

Scripps Clinic Carmel Valley

San Diego, California, 92130, United States

Location

Skin Search of Rochester, Inc.

Rochester, New York, 14623, United States

Location

Dermatology, Laser & Vein Specialists of the Carolinas, PLLC

Charlotte, North Carolina, 28207, United States

Location

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, 78550, United States

Location

MeSH Terms

Conditions

Warts

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: William A. Knape
• Organization: Pulse Biosciences, Inc.

bill.knape@pulsebiosciences.com

(919) 757-2033

Study Officials

• Richard Nuccitelli, PhD

  Pulse Biosciences, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 18, 2020
• Study Start: July 17, 2019
• Primary Completion: June 9, 2020
• Study Completion: December 1, 2020
• Last Updated: July 27, 2023
• Results First Posted: July 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)