Study of the ReGelTec HYDRAFIL System

  • STATUS
    Recruiting
  • End date
    Jan 4, 2024
  • participants needed
    50
  • sponsor
    ReGelTec, Inc.
Updated on 21 March 2022

Summary

A study designed to treat patients with back pain associated with degenerative lumbar disc disease.

Description

As people age, the nucleus pulposus reduces in volume which leads to annular bulging and biomechanical instability that produces altered load bearing forces between the anterior and posterior spinal elements (i.e., discs and facets). Loss of volume of the nucleus pulposus directly affects disc height, often causing pain, numbness or motor weakness due to contact with nerve roots or the spinal cord. The ReGelTec HYDRAFIL System may offer some potential advantages over conventional, spinal fusion and total disc replacement techniques applied in the treatment of symptomatic lumbar degenerative disc disease (DDD). Nucleus augmentation (NA) provides the opportunity to address lumbar DDD in a percutaneous approach while preserving function. Conceptually, nucleus augmentation will add to the armamentarium of surgical techniques for treating moderate to severe DDD to provide an early stage device-based intervention to augment the vertebral segment, and arrest changes that lead to progressive degeneration and ultimately may lead to more invasive surgeries such as discectomy, total disc replacement or spinal fusion.

Details
Condition Degenerative Disc Disease
Treatment HYDRAFIL
Clinical Study IdentifierNCT04984629
SponsorReGelTec, Inc.
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

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 12 weeks 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 imaging and provocative discography and/or anaesthetic discography at L1-L2, L2-L3, L3-L4, L4-L5, and L5-S1
Patients presenting with a pain level of ≥ 4 out of 10 on the NRS scale and an Oswestry Disability Index (ODI) score of ≥ 30
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 >10 at the incident level] and other deformity conditions that may compromise the study
Subjects with arachnoiditis
Subjects who are prisoners of wards or 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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