N/A
N=124
CellFX System for the Treatment of Cutaneous Non-Genital Warts
Warts · Warts Hand · Verruca
Bottom Line
View on ClinicalTrials.gov: NCT04554394 ↗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
| Outcome | Result | p-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)
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.