Discogenic Low Back PainNCT06860867
PerQdisc Traditional Feasibility Trial.
A study testing PerQdisc in people with Discogenic Low Back Pain, run by Spinal Stabilization Technologies at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Discogenic Low Back Pain
- What is being tested?
- PerQdisc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 8 sitesUnited States
- Study dates
- 10 Jan 2025to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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]
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- 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
- Subject is appropriate candidate for the PerQdisc surgical approach [as defined in the surgical technique guide].
Who cannot join
- 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.
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- 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]
- Subject has ≥4 mm dynamic spondylolisthesis [measured via flexion/extension x-rays]
- Subject has > 20 degree range of motion at the index level [measured via flexion/extension x-rays]
- Subject has a history of any invasive malignancy (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).
- Subject has an active systemic infection or infection at the operative site.
- 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.
- Subject has a known allergy to silicone or barium sulfate.
- Subject has been diagnosed with fibromyalgia, hepatitis, rheumatoid arthritis, lupus erythematosus, AIDs, ARC, HIV, or an autoimmune disease that affects the musculoskeletal system.
- Subject has been diagnosed with Paget's disease, osteomalacia or any other metabolic bone disease.
- 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 DSM-5
- Subject has morbid obesity defined as a body mass index (BMI) > 40.
- Subject participated in an investigational drug or another medical device study within the last 30 days prior to surgery.
- Subject has Osteoporosis, defined as a T-score ≤ -2.5.
- An existing DEXA is allowed if completed within 6 months of subject surgery.
- 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.
- Female subjects who are pregnant or are trying to become pregnant during the course of the trial.
- Subject has diabetes mellitus (Type 1 or 2) requiring daily insulin management.
- Subject belongs to a vulnerable population or has a condition such that his/her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g. developmentally disabled, prisoner, chronic alcohol/ substance abuser)
- Subject is currently receiving worker's compensation or is involved in any litigation for medical negligence, trauma, or worker's compensation.
- Subject has lumbar scoliosis > 10 degrees at index level.
- Subject has a large, rectangular or irregularly shaped Schmorl's node with an associated active inflammatory process (Modic I changes).
- Subject has motion of < 3 degrees on pre-operative lateral flexion/extension radiographs at index level.
- Subject has opioid medication usage > 60 MME (morphine milligram equivalent)/day or change in opioid prescription within 60 days of surgery.
- Subject has a preoperative VAS right or left leg pain score > the preoperative VAS Back score.
- Subject has a history of vertebral fractures in the lumbar spine.
- Subject has evidence of severe compression of cauda equina.
- 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.
- Subject has low back pain (LBP) of non-spinal or unknown etiology.
- Subject is unable to undergo X-ray, MRI, or other radiographic assessments, including discography.
- 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.
- 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.
- 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.
- Subject has myelopathy.
- Subject has primarily leg pain with associated nerve root compression, in the opinion of the investigator.
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 5 recruiting
- Recruiting
Indiana Spine Group
Carmel, Indiana, 46032
Sheetal Vinayek, 317-715-5897, svinayek@indianaspinegroup.com
Paul Kraemer, MD
- Recruiting
Axis Spine Center
Coeur d'Alene, Idaho, 83854
Katie Chemodurow, 208-664-0291, Katelyn.chemodurow@nwsh.com
Roland Kent, MD
- Withdrawn
Hope Research Institute
Glendale, Arizona, 85308
- Withdrawn
SonoSpine
Oklahoma City, Oklahoma, 73159
- Recruiting
The CORE Institute
Phoenix, Arizona, 85023
Leesa Maczko, 623-537-5654, Leesa.maczko@more-foundation.org
Ali Araghi, DO
- Withdrawn
HOPE Research Institute
Phoenix, Arizona, 85032
- Recruiting
HonorHealth Research & Innovation Institute
Scottsdale, Arizona, 85251
Claudia Crooks, 602-258-2863, neuroscienceresearch@honorhealth.com
Luis Tumialan, MD
- Recruiting
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
Heather Bowman, hbowman@louisianaspine.org
Pierce Nunley, MD
About this study
Official title: A Multi-center Traditional Feasibility Trial of the PerQdisc Artificial Implant in Treatment of Single-level Discogenic Back Pain.
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).
- Conditions
- Discogenic Low Back Pain
- Being tested
- PerQdisc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerQdiscDevice
PerQdisc Artificial Implant
| Study group | Role | What they receive |
|---|---|---|
| PerQdisc | Experimental | 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. Receives: Device: PerQdisc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Composite Success
Clinical composite success is defined as improvement in pain and absence of qualified safety events.
Measured: 6 Months
Secondary outcomes (2)
ODI
ODI 15-point responder at Month 6
Measured: 6 Months
VAS Back
VAS Back pain 20mm responder at Month 6
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start10 Jan 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discogenic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spinal Stabilization Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860867
- Sponsor's protocol ID
- DISCPAIN1 TFS
- Status last verified
- Aug 2025
- First submitted
- 28 Feb 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Traditional Feasibility Trial of the PerQdisc Artificial Implant in Treatment of Single-level Discogenic Back Pain.
- ClinicalTrials.gov ID
- NCT06860867
- Acronym / sponsor ID
- DISCPAIN1 TFS
- Conditions
- Discogenic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Spinal Stabilization TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PerQdisc | Experimental | Device: PerQdiscThe 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. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (42 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PerQdiscPerQdisc Artificial Implant | Device | PerQdisc |
Primary outcome
Clinical Composite Success
Time frame: 6 Months
Clinical composite success is defined as improvement in pain and absence of qualified safety events.
2 secondary outcomes
ODI
Time frame: 6 Months
VAS Back
Time frame: 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PerQdisc in people with Discogenic Low Back Pain, run by Spinal Stabilization Technologies at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Molly Bond (1-800-484-1588, clinical@sstspine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Composite Success (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.