PerQdisc Traditional Feasibility Trial. (NCT06860867) | Clinical Trial Compass
RecruitingNot Applicable
PerQdisc Traditional Feasibility Trial.
United States5 participantsStarted 2025-01-10
Plain-language summary
This is a traditional feasibility study (TFS) study to evaluate the safety and effectiveness of the PerQdisc. The study is prospective, multicenter, and open label.
After a screening period, qualified participants will be enrolled and treated with the PerQdisc. Patients will not be blinded to their treatment. Participants will then complete the safety follow-up period.
Who can participate
Age range22 Years – 70 Years
SexALL
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Inclusion criteria
✓. Skeletally mature male or female subjects aged 22-70 (inclusive).
✓. Subject has a primary diagnosis of single level discogenic back pain caused by degenerative disc disease (L1 to L5) identified via MRI.
✓. Subject has an intact annulus (as determined by MRI) and endplates (as determined by MRI and X-ray) at the level to be treated.
✓. Subject must have failed to respond to a minimum of 6 months of conservative treatment for their back pain (e.g., physical therapy, medications, injections, ablations, lifestyle changes, etc.).
✓. Subject has a low back pain VAS ≥40 mm (4 cm).
✓. Subject has adequate disc height (≥6mm measured at the center of the disc) at the level to be treated. \[As measured by the investigator\]
✓. Subject is psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
✓. Subject has read and understands the IRB approved informed consent document prior to signing and dating the document and before the initiation of any study-related procedures
Exclusion criteria
✕. Subject has symptomatic degenerative disc disease at more than one lumbar level
✕. Subject has had a prior spinal fusion in the lumbar or thoracic intervertebral spaces.
✕. Subject has had any prior lumbar spine surgery (instrumented or non-instrumented)
✕. Subject has a significant disc herniation at the level to be treated. Significant is defined as a large, extruded herniation that creates a risk for expulsion.
✕. Subject has congenital moderate or severe spinal stenosis or epidural lipomatosis.
✕. Subject has spondylolisthesis (antero- or retrolisthesis) in static X-ray ≥3 mm \[measured via neutral lateral x-ray\]