Ignite Creation Date:
2024-05-06 @ 2:13 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04253418
Status:
TERMINATED
Last Update Posted:
2023-10-30
First Post:
2020-01-28
Brief Title:
Nano-Pulse Stimulation NPS in Sebaceous Hyperplasia Optimization Study
Sponsor:
Pulse Biosciences Inc
Organization:
Pulse Biosciences Inc
Study Overview
Official Title:
Prospective Open Label Multi-Center Non-Significant Risk Study of Nano-Pulse Stimulation NPS Technology in Healthy Adults With Sebaceous Hyperplasia
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study enrollment was halted due to a business decision by the Sponsor to focus resources on other clinical areas outside of dermatology
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary study objective is to evaluate the optimization of Nano-Pulse Stimulation NPS energy settings for lesion clearance of Sebaceous Hyperplasia SH lesions from facial areas of healthy adult subjects
Detailed Description:
Evaluate lesion clearance of treated facial Sebaceous Hyperplasia lesions using multiple sized treatment tips with microneedles
Evaluate lesion clearance of the treated Sebaceous Hyperplasia lesions using multiple energy settings levels at various time points
Evaluate skin effects and adverse event rate
Evaluate lesion clearance of the treated Sebaceous Hyperplasia lesions using multiple energy settings levels at various time points
Evaluate skin effects and adverse event rate
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?:
False
Is an FDA AA801 Violation?:
None