ClinicalTrials.gg
RecruitingNCT06860867Updated Nov 9, 2026

PerQdisc Traditional Feasibility Trial.

An interventional study of PerQdisc in Discogenic Low Back Pain, sponsored by Spinal Stabilization Technologies. Recruiting at 9 sites in United States. Open to participants aged 22 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Spinal Stabilization Technologies · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 10 months later.
Updated Nov 9, 2026Primary completion moved1 site addedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
22 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

The proposed investigation is a multicenter, prospective, traditional feasibility study of the PerQdisc. A minimum of N=5 subjects will be enrolled. Subjects will be enrolled in approximately 2 sites. Data analyses including all enrolled subjects meeting specific criteria will be submitted to the FDA to support a pivotal trial and used in trial planning. This study will evaluate the safety and effectiveness of the PerQdisc device in the treatment of single level discogenic back pain caused by degenerative disc disease (DDD) (L1 to L5).

02

Conditions studied

  • Discogenic Low Back Pain

Browse trials for

03

In context

Low Back Pain

2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.

This study's planned enrollment of 5 is below the median of 60 across 2,364 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Spinal Stabilization Technologies is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Skeletally mature male or female subjects aged 22-70 (inclusive).
  2. Subject has a primary diagnosis of single level discogenic back pain caused by degenerative disc disease (L1 to L5) identified via MRI.
  3. Subject has an intact annulus (as determined by MRI) and endplates (as determined by MRI and X-ray) at the level to be treated.
  4. 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.).
  5. Subject has a low back pain VAS ≥40 mm (4 cm).
  6. Subject has adequate disc height (≥6mm measured at the center of the disc) at the level to be treated. [As measured by the investigator]
  7. 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.
  8. Subject has read and understands the IRB approved document prior to signing and dating the document and before the initiation of any study-related procedures
  9. Subject is appropriate candidate for the PerQdisc surgical approach [as defined in the surgical technique guide].

Exclusion criteria

Exclusion Criteria:

  1. Subject has symptomatic degenerative disc disease at more than one lumbar level
  2. Subject has had a prior spinal fusion in the lumbar or thoracic intervertebral spaces.
  3. Subject has had a prior SI-joint fusion.
  4. Subject has a spinal cord stimulator.
  5. Subject has had any prior lumbar spine surgery (instrumented or non-instrumented)
  6. 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.
  7. Subject has congenital moderate or severe spinal stenosis or epidural lipomatosis.
  8. Subject has spondylolisthesis (antero- or retrolisthesis) in static X-ray ≥3 mm [measured via neutral lateral x-ray]
  9. Subject has ≥4 mm dynamic spondylolisthesis [measured via flexion/extension x-rays]
  10. Subject has > 20 degree range of motion at the index level [measured via flexion/extension x-rays]
  11. Subject has a history of any invasive (except non-melanoma skin cancer) unless treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 5 years (in particular, spinal tumors).
  12. Subject has an active systemic infection or infection at the operative site.
  13. Subject has evidence of symptomatic facet joint degeneration or disease where the investigator feels the facet is a major contributor to the subject's pain as diagnosed by injection and/or imaging.
  14. Subject has a known allergy to silicone or barium sulfate.
  15. Subject has been diagnosed with fibromyalgia, hepatitis, rheumatoid arthritis, lupus erythematosus, AIDs, ARC, , or an disease that affects the musculoskeletal system.
  16. Subject has been diagnosed with Paget's disease, osteomalacia or any other metabolic bone disease.
  17. Subject has current or recent history (defined ≤ 1 year prior to screening) of substance abuse (alcoholism and/or narcotic addiction) using standard medical definitions of
  18. Subject has morbid obesity defined as a (BMI) > 40.
  19. Subject participated in an drug or another medical device study within the last 30 days prior to surgery.
  20. Subject has Osteoporosis, defined as a T-score ≤ -2.5.

    1. An existing DEXA is allowed if completed within 6 months of subject surgery.
    2. For all subjects without an existing DEXA, the SCORE/MORES will be utilized to screen if a DEXA scan is indicated. If SCORE/MORES value ≥ 6, then a DEXA scan is required.
  21. Female subjects who are pregnant or are trying to become pregnant during the course of the trial.
  22. Subject has diabetes mellitus (Type 1 or 2) requiring daily insulin management.
  23. Subject belongs to a vulnerable population or has a condition such that his/her ability to provide , comply with follow-up requirements, or provide self-assessments is compromised (e.g. developmentally disabled, prisoner, chronic alcohol/ substance abuser)
  24. Subject is currently receiving worker's compensation or is involved in any litigation for medical negligence, trauma, or worker's compensation.
  25. Subject has lumbar scoliosis > 10 degrees at index level.
  26. Subject has a large, rectangular or irregularly shaped Schmorl's node with an associated active inflammatory process (Modic I changes).
  27. Subject has motion of \< 3 degrees on pre-operative lateral flexion/extension radiographs at index level.
  28. Subject has opioid medication usage > 60 MME (morphine milligram equivalent)/day or change in opioid prescription within 60 days of surgery.
  29. Subject has a preoperative VAS right or left leg pain score > the preoperative VAS Back score.
  30. Subject has a history of vertebral fractures in the lumbar spine.
  31. Subject has evidence of severe compression of cauda equina.
  32. Subject is on chronic anticoagulation therapy due to a bleeding disorder and is unable to safely stop anticoagulants or has taken anticoagulants within 3 days prior to procedure.
  33. Subject has low back pain (LBP) of non-spinal or unknown etiology.
  34. Subject is unable to undergo X-ray, MRI, or other radiographic assessments, including discography.
  35. Subject has a degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to spinal disease (not at index level), Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis.
  36. Subject has, in the opinion of the investigator, a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the device.
  37. In the opinion of the investigator the subject has a major psychiatric disorder that may interfere with the assessment of the safety or effectiveness of the device.
  38. Subject has myelopathy.
  39. Subject has primarily leg pain with associated nerve root compression, in the opinion of the investigator.
  40. Subject has an annular defect greater than 6mm that extends from the interior of the disc to the outer margin of the annulus as evaluated on MRI.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

  • Experimental
    PerQdisc

    The PerQdisc device is the first in a new category of contained in-situ filled and then cured lumbar spinal implant. The PerQdisc is intended to replace the nucleus pulposus in a single lumbar disc level, preserve motion and alleviate pain. The PerQdisc is a silicone membrane (barrier membrane) configured to be filled with a room temperature vulcanizing silicone (RTVS) that will cure within minutes, resulting in a final shape that conforms to the nucleus space created by the surgical removal of the diseased or damaged nucleus pulposus.

    Device: PerQdisc

Interventions

  • DevicePerQdisc

    PerQdisc Artificial Implant

06

What researchers measure

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

07

Study locations

6 of 9 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
1 site added
Show site
  • University of Miami · Miami, United States
Nov 9, 2026
Primary completion
Sep 30, 2026→Sep 30, 2027
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    1 site added
    Show site
    • University of Miami · Miami, United States
    Primary completion Sep 30, 2026→Sep 30, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06860867
Lead sponsor
Spinal Stabilization Technologies
Responsible party
Sponsor
First posted
Mar 6, 2025
Start date
Jan 10, 2025
Primary completion
Sep 30, 2027 (estimated)
Completion
Mar 31, 2030 (estimated)
Last update
Nov 9, 2026

Study contacts

Molly Bond
Contact
clinical@sstspine.com
1-800-484-1588

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion