Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442410
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2024-05-29
Brief Title:
Comparison of DTM SCS Therapy Combined With Conventional Medical Management CMM to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Spine Surgery
Sponsor:
MedtronicNeuro
Organization:
MedtronicNeuro
Study Overview
Official Title:
Comparison of Differential Target Multiplexed Spinal Cord Stimulation DTM SCS Therapy Combined With CMM to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Surgery
Status:
COMPLETED
Status Verified Date:
2024-06
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 purpose of this investigational study is to document the safety clinical effectiveness and health economic analytics of DTM SCS programming delivered through the Intellis neurostimulator in subjects with chronic intractable pain of the trunk with or without lower limb pain including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative treatment and are not candidates for lumbar spinal surgery
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN10663814 | REGISTRY | ISRCTN Registry | None |