WartsNCT04554394
CellFX System for the Treatment of Cutaneous Non-Genital Warts
A study testing CellFX Device in people with Warts and Warts Hand, run by Pulse Biosciences, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Warts, Warts Hand, Verruca
- What is being tested?
- CellFX Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 Jul 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 11Show fewer
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dermatology, Laser & Vein Specialists of the Carolinas, PLLC
Charlotte, North Carolina, 28207
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78550
Skin Search of Rochester, Inc.
Rochester, New York, 14623
Scripps Clinic Carmel Valley
San Diego, California, 92130
Investigate MD, LLC
Scottsdale, Arizona, 85255
About this study
Official title: A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation™ (NPS™) Treatment of Cutaneous Non-Genital Warts
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.
Read the 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.
- Conditions
- Warts, Warts Hand, Verruca
- Being tested
- CellFX Device
- Keywords
- CellFX, Nano-Pulse Stimulation, NPS, Clearance
- Medical subject headings
- Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CellFX DeviceDevice
The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.
| Study group | Role | What they receive |
|---|---|---|
| CellFX Treated Wart | Experimental | Treated wart with CellFX device intervention Receives: Device: CellFX Device |
| Non-treated Wart | No intervention | Control wart for each enrolled subject without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Verrucae Cleared
Percentage of Verrucae with Clearance (91-100% reduction)
Measured: 60-days post-last CellFX treatment
Secondary outcomes (1)
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)
Measured: 60-days post-last CellFX treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start17 Jul 2019
- Primary completion9 Jun 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulse Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Nuccitelli, PhD, Study chair, Pulse Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554394
- Sponsor's protocol ID
- NP-WP-010
- Status last verified
- Jun 2023
- First submitted
- 29 Aug 2020
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation™ (NPS™) Treatment of Cutaneous Non-Genital Warts
- ClinicalTrials.gov ID
- NCT04554394
- Acronym / sponsor ID
- NP-WP-010
- Conditions
- Warts, Warts Hand, Verruca
- Keywords
- CellFX, Nano-Pulse Stimulation, NPS, Clearance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Pulse Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CellFX Treated Wart | Experimental | Device: CellFX DeviceTreated wart with CellFX device intervention |
| Non-treated Wart | No intervention | –Control wart for each enrolled subject without intervention |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CellFX DeviceThe CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death. | Device | CellFX Treated Wart |
Primary outcome
Percentage of Verrucae Cleared
Time frame: 60-days post-last CellFX treatment
Percentage of Verrucae with Clearance (91-100% reduction)
1 secondary outcome
Subject Satisfaction
Time frame: 60-days post-last CellFX treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Warts
RecruitingObservational study
Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia
Idiopathic CD4+ Lymphocytopenia, Cryptococcal Meningitis
Not yet recruiting
Efficacy and Safety of Oral Ivermectin for Genital Warts
Genital Warts
Enrolling by invitationPhase 1/2
Base-Edited Hematopoietic Stem/Progenitor Cell Gene Therapy for Treatment of CXCR4-WHIM
WHIM, Warts
Active, not recruitingPhase 3
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)
Common Warts, Common Warts (Verruca Vulgaris)
RecruitingPhase 3
Long-Term Follow-up Study of Cantharidin (YCANTH [VP-102/TO-208]) in Patients With Common Warts (Verruca Vulgaris)
Common Warts (Verruca Vulgaris), Common Warts
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Nuccitelli, PhD study chair
Pulse Biosciences, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CellFX Device in people with Warts and Warts Hand, run by Pulse Biosciences, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Verrucae Cleared (time frame: 60-days post-last CellFX treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023; AzTrials last refreshed its copy on 7 Nov 2026.