Clinical trial NCT04554394: CellFX System for the Treatment of Cutaneous Non-Genital Warts
Official title: A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation™ (NPS™) Treatment of Cutaneous Non-Genital Warts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Warts
Warts Hand
Verruca
Keywords: CellFX
Nano-Pulse Stimulation
NPS
Clearance
Lead sponsor: Pulse Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-18
Enrollment: 62
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Percentage of Verrucae Cleared
timeFrame: 60-days post-last CellFX treatment
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: 60-days post-last CellFX treatment
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Investigate MD, LLC
state: Arizona
city: San Diego
country: United States
facility: Scripps Clinic Carmel Valley
state: California
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
state: North Carolina
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
Study officials:
affiliation: Pulse Biosciences, Inc.
name: Richard Nuccitelli, PhD
role: STUDY_CHAIR
References: