Warts Clinical Trial
Official title:
A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation™ (NPS™) Treatment of Cutaneous Non-Genital Warts
Verified date | June 2023 |
Source | Pulse Biosciences, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 62 |
Est. completion date | December 1, 2020 |
Est. primary completion date | June 9, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
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) |
Country | Name | City | State |
---|---|---|---|
United States | Dermatology, Laser & Vein Specialists of the Carolinas, PLLC | Charlotte | North Carolina |
United States | Austin Institute for Clinical Research, Inc. | Pflugerville | Texas |
United States | Skin Search of Rochester, Inc. | Rochester | New York |
United States | Scripps Clinic Carmel Valley | San Diego | California |
United States | Investigate MD, LLC | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
Pulse Biosciences, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Verrucae Cleared | Percentage of Verrucae with Clearance (91-100% reduction) | 60-days post-last CellFX treatment | |
Secondary | 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 |
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