CellFX System for the Treatment of Cutaneous Non-Genital Warts

Not Applicable

Completed

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.

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
CellFX Treated Wart	CellFX Device	Treated wart with CellFX device intervention

Primary Outcome Measures

Name	Time	Method
Percentage of Verrucae Cleared	60-days post-last CellFX treatment	Percentage of Verrucae with Clearance (91-100% reduction)

Secondary Outcome Measures

Name	Time	Method
Subject Satisfaction	60-days post-last CellFX treatment	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)

Locations (5): Investigate MD, LLC
🇺🇸
Scottsdale, Arizona, United States
Skin Search of Rochester, Inc.
🇺🇸
Rochester, New York, United States
Austin Institute for Clinical Research, Inc.
🇺🇸
Pflugerville, Texas, United States
Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
🇺🇸
Charlotte, North Carolina, United States
Scripps Clinic Carmel Valley
🇺🇸
San Diego, California, United States