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CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts

NCT04738734 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-11-24

Study results available
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Summary

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.

Conditions

  • Warts
  • Warts Hand
  • Verruca

Interventions

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.

DEVICE

Cryosurgery Liquid Nitrogen Sprayer

Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.

Sponsors & Collaborators

  • Pulse Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Nuccitelli, PhD · Pulse Biosciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-16
Primary Completion
2021-12-15
Completion
2022-09-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04738734 on ClinicalTrials.gov