CellFX System for the Treatment of Cutaneous Non-Genital Warts

Warts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04554394
• Other study ID #: NP-WP-010
• Status: Completed
• Phase: N/A
• Start date: July 17, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: June 2023
• Source: Pulse Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 1, 2020
• Est. primary completion date: June 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Verruca
• Warts
• Warts Hand

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pulse Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Verrucae Cleared	Percentage of Verrucae with Clearance (91-100% reduction)	60-days post-last CellFX treatment
Secondary	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