PerQdisc Traditional Feasibility Trial.

NCT06860867 | Recruiting DMC FDA Device

• 1 other identifier: DISCPAIN1 TFS
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Discogenic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Clinical Composite Success

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

  6 Months

Secondary Outcomes (2)

• ODI

  6 Months

• VAS Back

  6 Months

Study Arms (1)

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.

Device: PerQdisc

Interventions

PerQdisc DEVICE

PerQdisc Artificial Implant

PerQdisc

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 \[as defined in the surgical technique guide\].

You may not qualify if:

• 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 \[measured via neutral lateral x-ray\]
• 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.

Sponsors & Collaborators

• Spinal Stabilization Technologies: lead

Study Sites (9)

Hope Research Institute

Glendale, Arizona, 85308, United States

WITHDRAWN

The CORE Institute

Phoenix, Arizona, 85023, United States

RECRUITING

HOPE Research Institute

Phoenix, Arizona, 85032, United States

WITHDRAWN

HonorHealth Research & Innovation Institute

Scottsdale, Arizona, 85251, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

NOT YET RECRUITING

Axis Spine Center

Coeur d'Alene, Idaho, 83854, United States

RECRUITING

Indiana Spine Group

Carmel, Indiana, 46032, United States

RECRUITING

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

RECRUITING

SonoSpine

Oklahoma City, Oklahoma, 73159, United States

WITHDRAWN

Central Study Contacts

Molly Bond

CONTACT

1-800-484-1588; clinical@sstspine.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 6, 2025
• Study Start: January 10, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2030
• Last Updated: March 24, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)