CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
CellFX System Device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04738734
NCT04738734N/ACompleted

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

Pulse Biosciences, Inc.·interventional·Posted Feb 4, 2021·Updated Nov 24, 2023

In Brief

A clinical study evaluating CellFX System Device and Cryosurgery Liquid Nitrogen Sprayer for Warts and 2 related conditions. Completed, enrolled 150 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 4, 2021
Enrollment StartFeb 16, 2021
Primary CompletionDec 15, 2021
Study CompletionSep 25, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 5.4 years ago

Interventions

CellFX System 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.

Cryosurgery Liquid Nitrogen Sprayerdevice

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