Health TrialsbyHealthPanel

PerQdisc Traditional Feasibility Trial.

ConditionDiscogenic Low Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorSpinal Stabilization Technologies

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • PerQdisc

    Device

    PerQdisc Artificial Implant

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: PerQdiscExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Composite Success

Clinical composite success is defined as improvement in pain and absence of qualified safety events.

Time frame
6 Months

Secondary outcomes

1

ODI

ODI 15-point responder at Month 6

Time frame
6 Months
2

VAS Back

VAS Back pain 20mm responder at Month 6

Time frame
6 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spinal Stabilization Technologies

Lead sponsor

Source ClinicalTrials.gov
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