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CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts

Warts Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04738734
Study type Interventional
Source Pulse Biosciences, Inc.
Contact
Status Completed
Phase N/A
Start date February 16, 2021
Completion date September 25, 2022
View Details
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