Ignite Creation Date:
2024-05-06 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03612570
Status:
COMPLETED
Last Update Posted:
2024-04-12
First Post:
2018-07-27
Brief Title:
Nano-Pulse Stimulation NPS in Sebaceous Hyperplasia
Sponsor:
Pulse Biosciences Inc
Organization:
Pulse Biosciences Inc
Study Overview
Official Title:
Evaluation of Nano-Pulse Stimulation NPS in Sebaceous Hyperplasia
Status:
COMPLETED
Status Verified Date:
2024-04
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 open label muti-center study evaluates the use of Nano-Pulse Stimulation NPS in the treatment of Sebaceous Hyperplasia SH lesions less than 25mm in size
Detailed Description:
The study is designed with each subject serving as his or her own control A total of up to 75 subjects with 2-5 qualifying SH lesions will be enrolled and treated with either a 15-mm x 15-mm or 25-mm x 25-mm tip All treated lesions will receive at least one NPS treatment and evaluated at 30 days for lesion clearance Initial lesions scored as Not Clear or Partially Clear may undergo a second NPS treatment All subjects will have their lesions evaluated at 60 days post-primary or secondary treatment
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