Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT05732818
Status:
SUSPENDED
Last Update Posted:
2025-08-26
First Post:
2023-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy 3
Sponsor:
Spinal Stabilization Technologies
Organization:
Study Overview
Official Title:
Clinical Investigation Plan First in Human Trial Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy "LOPAIN3"
Status:
SUSPENDED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was suspended as enrollment of patients was difficult and no participants could be found for two years.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOPAIN3
Brief Summary:
This study is a First in Human, prospective, multi-center clinical study intended to collect safety and performance information for the Spinal Stabilization Technologies PerQdisc® Nucleus Replacement System and procedure concurrently following a successful discectomy using a minimally invasive posterolateral (MIPL) approach. Patients that are at least 21 years or older, presenting with symptomatic radiculopathy from a focal lumbar disc herniation that requires surgical decompression will be included in this study.
Detailed Description:
The PerQdisc® Nucleus Replacement System is comprised of an in situ formed silicone-based prosthesis with its delivery system, implant fill device, dispenser gun, a disc access system and two different imaging balloons. For this trial, the PerQdisc® will be implanted using minimally invasive posterolateral (MIPL) approach. The implanted device provides an effective means of replacing dysfunctional nucleus pulposus while supporting the native annulus fibrosis to bridge annular defects.
Patients that suffer clinically significant lumbar disc herniations currently undergo discectomy procedures to relieve nerve root compression. The standard discectomy procedure does not correct the annular defect associated with the herniation and is associated with a risk for re-herniation. In addition, the progressive loss of disc height and overall lack of disc turgor and weight bearing capacity is thought to be associated with downstream degenerative changes that may lead to chronic low back pain and premature spondylosis.
Patients that suffer clinically significant lumbar disc herniations currently undergo discectomy procedures to relieve nerve root compression. The standard discectomy procedure does not correct the annular defect associated with the herniation and is associated with a risk for re-herniation. In addition, the progressive loss of disc height and overall lack of disc turgor and weight bearing capacity is thought to be associated with downstream degenerative changes that may lead to chronic low back pain and premature spondylosis.
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?: