Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-02-25 @ 5:52 PM
Study NCT ID:
NCT04554394
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2020-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CellFX System for the Treatment of Cutaneous Non-Genital Warts
Sponsor:
Pulse Biosciences, Inc.
Organization:
Study Overview
Official Title:
A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation™ (NPS™) Treatment of Cutaneous Non-Genital Warts
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: