Is a
Clinical Study attributes
NCT Number
Health Conditions in Trial
Trial Recruitment Size
120
Trial Sponsor
Clinical Trial Start Date
January 10, 2020
0Primary Completion Date
March 20, 2021
0Study Completion Date
March 20, 2021
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Device Feasibility0
Intervention Type
Device0
Intervention Name
HD Study Electrode0
Interventional Trial Phase
Not Applicable0
Participating Facility
Official Name
Effects of Novel SCS Paddle on Intraoperative Neuromonitoring Recording0
Last Updated
March 1, 2023
0Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Study summary
The purpose of this study is to demonstrate safety and efficacy of a new spinal cord stimulation paddle electrode which is able to target the dorsal horns, dorsal nerve roots, and dorsal columns. The research electrode ("Study Electrode") is designed to answer basic physiological clinical research questions. It may inform future device therapy development, but the Study Electrode is not a product that will be marketed or sold. The Investigators believe the protocol is a Non-Significant Risk study answering basic physiological research questions, which may be performed under hospital IRB approval.
Timeline
No Timeline data yet.
Further Resources
No Further Resources data yet.
