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CellFX System for the Treatment of Cutaneous Non-Genital Warts

Warts Clinical Trial

Official title:
A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation™ (NPS™) Treatment of Cutaneous Non-Genital Warts

Clinical Trial 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.

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. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04554394
Study type Interventional
Source Pulse Biosciences, Inc.
Contact
Status Completed
Phase N/A
Start date July 17, 2019
Completion date December 1, 2020
View Details
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