Mode
Text Size
Log in / Sign up
N/A N=124 Randomized Treatment

CellFX System for the Treatment of Cutaneous Non-Genital Warts

Warts · Warts Hand · Verruca

Enrolled (actual)
124
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Percentage of Verrucae Cleared — 67.6 percentage of verrucae clearance

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
CellFX Device (Device)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
Pulse Biosciences, Inc.
Primary completion
Jun 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Verrucae Cleared
67.6
SECONDARY
Subject Satisfaction
73.7

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.

Eligibility Criteria

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04554394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search