Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:25 PM
Study NCT ID:
NCT05837234
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-29
First Post:
2023-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultra Low Frequency Spinal Cord Stimulation for Chronic Low Back Pain
Sponsor:
Presidio Medical, Inc
Organization:
Study Overview
Official Title:
A Prospective, Open-Label, Multi-Center Trial to Evaluate the Safety and Effectiveness of Ultra Low Frequency Spinal Cord Stimulation in Patients With Chronic Low Back Pain
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
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 Presidio Medical Ultra Low Frequency (ULF™) Spinal Cord Stimulation (SCS) System is intended to provide pain relief to participants who have been clinically diagnosed with chronic low back pain with or without leg pain.
Detailed Description:
This is a prospective, open-label, multi-center clinical trial in which participants with chronic low back pain (CLBP) with/without leg pain will be invited to enroll and undergo treatment with the ULF SCS system. The purpose of this study is to evaluate the safety and effectiveness of ULF SCS over a 3-year period.
Study Oversight
Has Oversight DMC:
True
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?: