Ignite Creation Date:
2024-05-06 @ 2:12 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04249115
Status:
TERMINATED
Last Update Posted:
2023-10-30
First Post:
2020-01-27
Brief Title:
Nano-Pulse Stimulation NPS in Seborrheic Keratosis 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 Seborrheic Keratosis
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 Seborrheic Keratosis SKs from off-facial areas of healthy adults
Detailed Description:
Evaluate lesion clearance rate of SKs in off-face locations post-treatment versus baseline using multiple sized treatment tips with microneedles
Evaluate the clearance of the treated SKs using multiple energy settings at various time points initial procedure compared baseline
Evaluate skin effects and adverse event rate
Evaluate the clearance of the treated SKs using multiple energy settings at various time points initial procedure compared baseline
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