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 range
22 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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. \[As measured by the investigator\]
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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 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.
. Subject has spondylolisthesis (antero- or retrolisthesis) in static X-ray ≥3 mm \[measured via neutral lateral x-ray\]