CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts

November 16, 2023 updated by: Pulse Biosciences, Inc.

A Multicenter, Prospective, Randomized, Comparison IDE Study Between the Pulse Biosciences CellFX System and Cryosurgery for the Treatment of Cutaneous Non-Genital Common Warts

This prospective, multicenter, single-blinded, randomized comparison study is designed to compare the safety and effectiveness of the CellFX System to Cryosurgery for the clearance of cutaneous non-genital common warts on all areas of the body excluding the scalp, nose, within the orbital region of the face, plantar or periungual area in healthy adult subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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. Macrophotography of all study warts will be captured along with a blinded site Investigator to characterize wart healing, wart clearance and wart reduction. All subjects will be followed at 7, 30, 60, and 90-days following the last CellFX or Cryosurgical Procedure. All wart lesions are eligible for up to a total of 3 treatments over the course of the study. Adverse events will be documented.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85255
        • Investigate MD
    • California
      • Beverly Hills, California, United States, 90210
        • Moy-Fincher-Chipps Dermatology
    • Colorado
      • Greenwood Village, Colorado, United States, 80111
        • AboutSkin Dermatology and DermSurgery
    • Florida
      • Clearwater, Florida, United States, 34685
        • Palm Harbor Dermatology
    • Illinois
      • Joliet, Illinois, United States, 60435
        • Oak Dermatology
    • New York
      • New York, New York, United States, 10022
        • JUVA Skin & Laser Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Dermatology, Laser & Vein Specialists of the Carolinas
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Dermatology & Laser Center of Charleston
    • Texas
      • Houston, Texas, United States, 77056
        • Austin Institute for Clinical Research, Inc.
      • Pflugerville, Texas, United States, 78550
        • Austin Institute for Clinical Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects must be at least 21 and not older than 80 years of age
  • Subject has a Fitzpatrick Skin Type I, II, III or IV.
  • Subject gives voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
  • Subject must comply with study procedures including all follow-up visits.
  • Subject is willing to have warts treated in a single treatment session and understands that their warts may undergo multiple treatment sessions at subsequent visits.
  • Subject must have a minimum of 2 warts and up to 8 warts to be treated.
  • Subject with a clinical diagnosis of common warts located on hands and fingers or other body areas that are not located on the scalp, nose, within the orbital region of the face, plantar, genital or periungual area.
  • For study purposes, the warts must be no greater than 3 mm in height and must not exceed 10mm x 10mm at their largest dimension.
  • Each wart must appear alone and discrete and not appear in clusters.
  • Each wart must have been present for at least 4 weeks.
  • Subject consents to have photographs taken of the warts.
  • Subject agrees to refrain from using all other wart removal products or treatments (e.g.

topical medication including over-the-counter medications) during the study period.

Exclusion Criteria:

  • Subject with more than 8 visible warts in total anywhere on the body.
  • Subject has flat, periungual, subungual, genital, anal, mosaic, plantar or filiform warts.
  • Subject has an implantable electronic medical device.(i.e., pacemaker, implantable cardioverter defibrillator)
  • Subject has an active infection or history of infection in designated test area within 90 days prior to first treatment.
  • Subject is taking antihistamines, including those used for gastric symptoms.
  • Subject is prone to Koebnerization or has any of the following conditions (e.g., psoriasis, vitiligo, lichen planus, or an autoimmune disorder of the skin)
  • Subject is not willing or able to sign the Informed Consent.
  • Subject is known to be immune compromised.
  • Subject has allergies 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.
  • Have any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study.
  • Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study.
  • Subject was previously treated with CellFX for warts.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CellFX Procedure
CellFX device using pre-defined energy protocols
Device: CellFX System 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.
Active Comparator: Cryosurgical Procedure
Cryosurgery will be standardized across all investigational sites. Investigators will perform the Cryosurgical procedure using the Brymill Cry-Ac B700 Liquid Nitrogen Sprayer.
Device: Cryosurgery Liquid Nitrogen Sprayer
Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Warts Resolved
Time Frame: 30 days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months
The primary effectiveness endpoint is the percentage of warts resolved or cleared as assessed "live" by the blinded site investigator at 30 days after the last treatment with CellFX or Cryosurgical Procedure.
30 days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months
Percentage of Warts Treated With Skin Textural Changes
Time Frame: 30 days from the last CellFX or Cryosurgical Procedure up to a maximum of 3 months
The safety endpoint is the percentage of warts with skin textural changes where the wart was originally treated and showed textual changes of the surrounding skin where the wart was treated and included; scabbing, swelling, crusting, blister, or ulceration when assessed by the blinded site investigator.
30 days from the last CellFX or Cryosurgical Procedure up to a maximum of 3 months
Presence of Pigmentary and Scarring Skin Changes
Time Frame: 90 days from the last CellFX or Cryosurgical Procedure up to a maximum of 3 months
The skin change safety event is defined as the presence of hyperpigmentation, hypopigmentation, or scarring as assessed by the blinded site investigator.
90 days from the last CellFX or Cryosurgical Procedure up to a maximum of 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Wart Resolution
Time Frame: 30 days from the last CellFX or Cryosurgical Procedure
Wart resolution will be assessed by three independent observers, blinded to treatment assignment, who will classify the response for each wart as "resolved" or "not resolved" based on photographs.
30 days from the last CellFX or Cryosurgical Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pulse Biosciences, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Richard Nuccitelli, PhD, Pulse Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NP-WC-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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