CellFX System for the Treatment of Cutaneous Non-Genital Warts

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Warts, Warts Hand, Verruca

Intervention / Treatment
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* Device: CellFX Device


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CellFX Treated Wart<br>Treated wart with CellFX device intervention | Device: CellFX Device<br>* The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.<br>|
| No Intervention: Non-treated Wart<br>Control wart for each enrolled subject without intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Verrucae Cleared | Percentage of Verrucae with Clearance (91-100% reduction) | 60-days post-last CellFX treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NPS, CellFX, Nano-Pulse Stimulation, Clearance