Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06030284
Status:
WITHDRAWN
Last Update Posted:
2023-11-03
First Post:
2023-08-11
Brief Title:
The True Efficacy of Burst Spinal Cord Stimulation in the Management of Intractable Low Back Pain TRU-BURST
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
The True Efficacy of Burst Spinal Cord Stimulation in the Management of Intractable Low Back Pain
Status:
WITHDRAWN
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Decision was taken to consider other opportunities for collecting sham-controlled data for BurstDR SCS
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this prospective multi-center randomized triple-blind sham-controlled study with parallel economic evaluation is to test the analgesic superiority of BurstDR-SCS compared to sham stimulation using both traditional patient-reported pain outcome measures and objective physiologic data collected from patient-worn biosensors The endpoints associated with these objectives will be studied across a follow-up period of 6 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None