Degenerative Disc Disease Clinical Trial
Official title:
Prospective, Single Arm, Non-randomized, Traditional Feasibility Study to Evaluate the Safety and Performance of the ReGelTec HYDRAFIL System
Verified date | November 2023 |
Source | ReGelTec, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A study designed to treat patients with back pain associated with degenerative lumbar disc disease.
Status | Active, not recruiting |
Enrollment | 35 |
Est. completion date | November 6, 2025 |
Est. primary completion date | November 6, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years to 80 Years |
Eligibility | Inclusion Criteria: - Present with predominant low back pain and symptoms of DDD of the lumbar region of at least 6 months duration - Failure to have their symptoms resolve or reduce following 6 months conservative care (pain medication and/or physical therapy) - Male or female patients aged 22 to 80 years, inclusive - Presence of DDD on magnetic resonance imaging (MRI) scan with global disc degeneration. Modified Pfirrmann grades 5 to 8 as characterized by MRI - The presence of one or two symptomatic discs exhibiting degeneration contained within a competent outer annulus as determined by MRI and provocative discography and/or anaesthetic discography at L1-S1 - Patients who are legally competent and able to understand the nature, scope and aim of the clinical investigation - Signed an informed subject consent form in a language in which they are fluent Exclusion Criteria: - History of or current systemic or local infection - Annular tear or defect that shows free contrast extravasation into the epidural space during or after discography - Presence of disc herniation that accounts for the majority of the patient's symptoms - Subjects with Modic type 3 changes - Subjects with trans-endplate disc herniations or Schmorl's nodes - Neurogenic claudication due to spinal stenosis - Previous back surgery at the target level of the lumbar spine - Evidence of severe compression of cauda equina - Spinal segmental instability (spondylolysis or spondylolisthesis: Grade >1), spinal canal stenosis, isthmus pathology, scoliosis [Cobb angle >20 at the incident level] and other deformity conditions that may compromise the study - Subjects with arachnoiditis - Subjects who are prisoners or wards of the courts - Subjects involved in active litigation including worker's compensation cases - Subjects with low back pain of non-spinal or unknown etiology - Subjects with severe osteoporosis or metabolic bone disease - Subjects who have a history of or are current abusers of alcohol or drugs (using definition criteria from the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)) - If female, patients who are pregnant or are trying to become pregnant during the course of the trial. (due to risks of additional radiation exposures) - Failure to understand informed consent or participation in any other clinical study - Body Mass index (BMI) greater than 40 - Patients with active tumors in the spinal region - Patients who have been diagnosed to diabetes mellitus - Patients who have a sensitivity or allergy to the implant materials |
Country | Name | City | State |
---|---|---|---|
Canada | Beam Interventional & Diagnostic Imaging | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
ReGelTec, Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Success | Successful implantation of the ReGelTec HYDRAFIL System implant in a lumbar disc nucleus | post-treatment | |
Secondary | Back pain as measured by NRS | Decrease in Numeric Rating Scale (NRS) Score - Back Pain | 3, 6, 12 and 24 months | |
Secondary | Function as measured by ODI | Maintenance of, or further improvement in the Oswestry Disability Index (ODI) Score | 3, 6, 12 and 24 months | |
Secondary | Safety of the ReGelTec Implant by demonstrating durability over the long term and no unanticipated safety concerns that arise | Freedom from Device or Operative Related Serious Adverse Events (SAEs) | 3, 6, 12 and 24 months |
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