CellFX System for the Treatment of Cutaneous Non-Genital Warts

NCT ID: NCT04554394

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-17
• Study Completion Date: 2020-12-01

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.

Conditions

Warts; Warts Hand; Verruca

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CellFX Treated Wart

Treated wart with CellFX device intervention

Group Type: EXPERIMENTAL

CellFX Device

Intervention Type: 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.

Non-treated Wart

Control wart for each enrolled subject without intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pulse Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Nuccitelli, PhD

Role: STUDY_CHAIR

Pulse Biosciences, Inc.

Locations

Investigate MD, LLC

Scottsdale, Arizona, United States

Scripps Clinic Carmel Valley

San Diego, California, United States

Skin Search of Rochester, Inc.

Rochester, New York, 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

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

NP-WP-010

Identifier Type: -

Identifier Source: org_study_id