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CellFX System for the Treatment of Cutaneous Non-Genital Warts

Primary Purpose

Warts, Warts Hand, Verruca

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CellFX Device
Sponsored by
Pulse Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Warts focused on measuring CellFX, Nano-Pulse Stimulation, NPS, Clearance

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Investigate MD, LLC
  • Scripps Clinic Carmel Valley
  • Skin Search of Rochester, Inc.
  • Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
  • Austin Institute for Clinical Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CellFX Treated Wart

Non-treated Wart

Arm Description

Treated wart with CellFX device intervention

Control wart for each enrolled subject without intervention

Outcomes

Primary Outcome Measures

Percentage of Verrucae Cleared
Percentage of Verrucae with Clearance (91-100% reduction)

Secondary Outcome Measures

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)

Full Information

First Posted
August 29, 2020
Last Updated
July 25, 2023
Sponsor
Pulse Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04554394
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 17, 2019 (Actual)
Primary Completion Date
June 9, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pulse Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Warts, Warts Hand, Verruca
Keywords
CellFX, Nano-Pulse Stimulation, NPS, Clearance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CellFX Treated Wart
Arm Type
Experimental
Arm Description
Treated wart with CellFX device intervention
Arm Title
Non-treated Wart
Arm Type
No Intervention
Arm Description
Control wart for each enrolled subject without intervention
Intervention Type
Device
Intervention Name(s)
CellFX Device
Intervention Description
The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.
Primary Outcome Measure Information:
Title
Percentage of Verrucae Cleared
Description
Percentage of Verrucae with Clearance (91-100% reduction)
Time Frame
60-days post-last CellFX treatment
Secondary Outcome Measure Information:
Title
Subject Satisfaction
Description
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)
Time Frame
60-days post-last CellFX treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Nuccitelli, PhD
Organizational Affiliation
Pulse Biosciences, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Investigate MD, LLC
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Scripps Clinic Carmel Valley
City
San Diego
State/Province
California
ZIP/Postal Code
92130
Country
United States
Facility Name
Skin Search of Rochester, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Austin Institute for Clinical Research, Inc.
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78550
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CellFX System for the Treatment of Cutaneous Non-Genital Warts

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