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Clinical Trials

Nucleus 161 

Feasibility Study for an Artificial Spinal Disc Replacement (PerQdisc). 

N161 is a clinical trial to study the feasibility of implanting the PerQdisc device in the lumbar spine of patients suffering from chronic low back pain. Patients are assessed for pain and disability using standardized patient reported outcome measures as well as X-ray and MRI imaging. 

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Nucleus 181 

Safety Study for An Artificial Disc Replacement (PerQdisc). 

N181 is a clinical trial to study the safety of implanting PerQdisc device in the lumbar spine of patients suffering from chronic low back pain. Pa-tients are assessed for pain and disability using standardized patient reported outcome measures as well as X-ray and MRI imaging. 

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Clinical Trial Status
Type
Enrollment
Number of Patients
Planning
Nucleus 161
Feasibility
Complete
6
1 year follow up complete
2 year follow up in progress
Safety/CE Registry Chronic low back pain in single-level degenerative disc disease.
Enrolling:
  • Belgium
  • Canada
  • Croatia
  • Germany
Additional countries will be added following Ethics Committee approvals.
15
First patient enrolled 05/2019
LOPAIN1
Enrolling
34 Patients
First patient enrolled
10/10/2019
Safety and Feasibility
Chronic low back pain in multi-level degenerative disc disease.
TBA
Registry
FDA/Health Canada
Future Trial
TBA
Planning