CellFX System for the Treatment of Cutaneous Non-Genital Warts

Completed · Not applicable

Conditions studied: Warts, Warts Hand, Verruca

In brief

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.

Key facts

Study ID

NCT04554394

Run by

Pulse Biosciences, Inc.

People needed

62

Starts

2019-07-17

Expected to finish

2020-12-01

Last updated by the study team

2023-07-27

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Investigate MD, LLC — Scottsdale, Arizona, United States
• Scripps Clinic Carmel Valley — San Diego, California, United States
• Skin Search of Rochester, Inc. — Rochester, New York, 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

Full record on ClinicalTrials.gov

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