Viewing Study NCT03846531



Ignite Creation Date: 2024-05-06 @ 12:47 PM
Last Modification Date: 2024-10-26 @ 1:04 PM
Study NCT ID: NCT03846531
Status: COMPLETED
Last Update Posted: 2023-08-22
First Post: 2019-02-17

Brief Title: Nano-Pulse Stimulation NPS in Seborrheic Keratosis Study
Sponsor: Pulse Biosciences Inc
Organization: Pulse Biosciences Inc

Study Overview

Official Title: Evaluation of Nano-Pulse Stimulation NPS in Patients With Seborrheic Keratosis
Status: COMPLETED
Status Verified Date: 2023-07
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: The primary purpose of this trial is to evaluate Nano-Pulse Stimulation NPS to clear or remove Seborrheic Keratosis SK lesions from off-facial areas of healthy adult subjects
Detailed Description: Evaluate Nano-Pulse Stimulation NPS to clear or remove Seborrheic Keratosis SK lesions from off-facial areas of healthy adult subjects

The specific objectives of this study are to

Document the non-treated appearance of off-face SKs
Evaluate the clearance of SKs in off-face locations post-treatment versus pre-treated appearance of the same lesion
Evaluate the clearance of the treated SKs at various points in time over several weeks following the initial procedure compared to the pre-treated SKs

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