Not a traditional drug phase: PerQdisc for Discogenic Low Back Pain
This is a traditional feasibility study (TFS) study to measure the safety and effectiveness of the PerQdisc. The study is prospective, multicenter, and open label.
Official registry: https://clinicaltrials.gov/study/NCT06860867 · Spinal Stabilization Technologies · enrollment listed as 5
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are PerQdisc. The registry lists allocation as na. This is a traditional feasibility study (TFS) study to measure the safety and effectiveness of the PerQdisc.
They plan to enroll about 5 people at 9 sites. Taking part typically means using or being fitted with a device plus check-ins.
Official title (unrewritten)
A Multi-center Traditional Feasibility Trial of the PerQdisc Artificial Implant in Treatment of Single-level Discogenic Back Pain.
Interventions: PerQdisc
Primary outcome (registry wording): Clinical Composite Success
Who it is for (from inclusion criteria)
- Ages 22 Years to 70 Years
- 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
Who the registry excludes
- 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 a prior SI-joint fusion
- Subject has a spinal cord stimulator
- 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
Public study contact (from the registry)
Molly Bond
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
9 listed- Hope Research Institute — Glendale, Arizona (withdrawn)
- The CORE Institute — Phoenix, Arizona (recruiting)
- HOPE Research Institute — Phoenix, Arizona (withdrawn)
- HonorHealth Research & Innovation Institute — Scottsdale, Arizona (recruiting)
- University of Miami — Miami, Florida (recruiting)
- Axis Spine Center — Coeur d'Alene, Idaho (recruiting)
- Indiana Spine Group — Carmel, Indiana (recruiting)
- Spine Institute of Louisiana — Shreveport, Louisiana (recruiting)
- SonoSpine — Oklahoma City, Oklahoma (withdrawn)
FAQ about this NCT record
Is NCT06860867 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06860867?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06860867?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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