NCT04738734

CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Pulse Biosciences, Inc. · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Warts
• Warts Hand
• Verruca

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-16
• Primary completion: 2021-12-15
• Completion: 2022-09-25
• First posted: 2021-02-04
• Last updated: 2023-11-24
• Results posted: 2023-11-21

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study