Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04738734
Status:
COMPLETED
Last Update Posted:
2023-11-24
First Post:
2021-01-31
Brief Title:
CellFX Comparison to Cryosurgery in Cutaneous Non-Genital Common Warts
Sponsor:
Pulse Biosciences Inc
Organization:
Pulse Biosciences Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-11
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None