CellFX System for the Treatment of Cutaneous Non-Genital Warts (NCT04554394) | Clinical Trial Compass
CompletedNot Applicable
CellFX System for the Treatment of Cutaneous Non-Genital Warts
United States62 participantsStarted 2019-07-17
Plain-language 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.
Who can participate
Age range21 Years – 80 Years
SexALL
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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
* Subjec…