Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-01 @ 8:30 PM
Study NCT ID:
NCT04004156
Status:
TERMINATED
Last Update Posted:
2025-05-21
First Post:
2019-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study for An Artificial Disc Nucleus Replacement to Treat Chronic Low Back Pain
Sponsor:
Spinal Stabilization Technologies
Organization:
Study Overview
Official Title:
Safety Study for An Artificial Disc Replacement "PerQdisc Nucleus Replacement Device" NUCLEUS 181
Status:
TERMINATED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial was terminated prematurely due to receipt of CE mark
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain.
Detailed Description:
This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device (NRD). The NRD is used for surgical replacement of a single nucleus pulposus between spinal lumbar discs L1-S1 using an anterior or lateral transpsoas approach. Currently the surgical gold standard involves spinal fusion of the affected vertebral bodies, reducing range of motion and increasing stress on other vertebral bodies. The goal of nucleus replacement is to reduce chronic low back pain by maintaining disc height while preserving range of motion.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: