CellFX System for the Treatment of Cutaneous Non-Genital Warts
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CellFX Treated Wart Lesion CellFX device using pre-defined energy protocols |
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.
|
Outcome Measures
Primary Outcome Measures
- Reduction in Wart Size [60-days post-last CellFX treatment]
The primary effectiveness is reduction in wart size and/or clearance using the following wart reduction scale; 0=Clear (91-100%), 1 (70-90%), 2 (50-69%), 3 (30-49%) to 4 (10-29%), and 5 (0-9%)
Secondary Outcome Measures
- Subject Satisfaction [60-days post-last CellFX treatment]
Satisfaction with reduction in wart size or clearance of wart measured using the following scale; 5 (Satisfied), 4 (Mostly Satisfied), 3 (Partially Satisfied), 2 (Dissatisfied), 1 (Highly Dissatisfied)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects must be at least 21 and not older than 80 years of age
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Subjects must be able to read and speak English or Spanish
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Subjects must sign a written informed consent to participate in the study, prior to any study related procedures
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Subject must have a minimum of two cutaneous non-genital warts, each not exceeding 10 x 10mm
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Subject is willing to undergo all study-mandated procedures
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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:
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Subject has an implantable electronic medical device. (pacemaker, implantable cardioverter defibrillator, etc.)
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Subject has cochlear implants
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Subject has an active systemic infection or history of an infection in the designated treatment area within 90 days of enrollment
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Subject has a history of and/or current tinnitus
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Subject is known to be immune-compromised
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Subject is taking a blood thinning medication (Antiplatelet, Anticoagulation, Factor Xa Inhibitor, etc.)
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Subject has Type 1 Diabetes and is insulin dependent
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Subject has a known allergy to Lidocaine or Lidocaine-like products
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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
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Subject has a comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
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Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigate MD, LLC | Scottsdale | Arizona | United States | 85255 |
| 2 | Scripps Clinic Carmel Valley | San Diego | California | United States | 92130 |
| 3 | Skin Search of Rochester, Inc. | Rochester | New York | United States | 14623 |
| 4 | Dermatology, Laser & Vein Specialists of the Carolinas, PLLC | Charlotte | North Carolina | United States | 28207 |
| 5 | Austin Institute for Clinical Research, Inc. | Pflugerville | Texas | United States | 78550 |
Sponsors and Collaborators
- Pulse Biosciences, Inc.
Investigators
- Study Chair: Richard Nuccitelli, PhD, Pulse Biosciences, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NP-WP-010