Study of the ReGelTec HYDRAFIL System

Launched by REGELTEC, INC. · Jul 21, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called the ReGelTec HYDRAFIL System for people experiencing back pain caused by degenerative disc disease (DDD) in the lower back. The trial is currently active but not recruiting new participants. It aims to help individuals who have had ongoing low back pain for at least six months and have not found relief through traditional treatments like pain medication or physical therapy. To be eligible, participants need to be between 22 and 80 years old and have specific imaging results showing degeneration in their spinal discs.

If you or someone you know qualifies for this trial, you can expect a thorough evaluation to determine if your condition meets the study criteria. Participants will be required to sign an informed consent form, meaning they will be fully informed about the trial and agree to take part. It’s important to note that there are certain conditions that would exclude participation, such as having a history of spinal surgery or certain types of disc problems. Overall, this study hopes to provide a new option for those struggling with chronic back pain related to degenerative disc disease.

Gender

ALL

Eligibility criteria

• 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