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CellFX System for the Treatment of Cutaneous Non-Genital Warts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04554394
Recruitment Status : Completed
First Posted : September 18, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Pulse Biosciences, Inc.

Study Description
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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
Warts Warts Hand Verruca Device: CellFX Device Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation™ (NPS™) Treatment of Cutaneous Non-Genital Warts
Actual Study Start Date : July 17, 2019
Actual Primary Completion Date : February 5, 2020
Actual Study Completion Date : July 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Warts

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Reduction in Wart Size [ Time Frame: 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 :
  1. Subject Satisfaction [ Time Frame: 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
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04554394


Locations
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United States, Arizona
Investigate MD, LLC
Scottsdale, Arizona, United States, 85255
United States, California
Scripps Clinic Carmel Valley
San Diego, California, United States, 92130
United States, New York
Skin Search of Rochester, Inc.
Rochester, New York, United States, 14623
United States, North Carolina
Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
Charlotte, North Carolina, United States, 28207
United States, Texas
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, United States, 78550
Sponsors and Collaborators
Pulse Biosciences, Inc.
Investigators
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Study Chair: Richard Nuccitelli, PhD Pulse Biosciences, Inc.
More Information
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Responsible Party: Pulse Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT04554394    
Other Study ID Numbers: NP-WP-010
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Pulse Biosciences, Inc.:
CellFX
Nano-Pulse Stimulation
NPS
Clearance
Additional relevant MeSH terms:
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Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Infections
 Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases