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HYDRAFIL for Back Pain Due to Degenerative Disc Disease
N/A
Waitlist Available
Led By Olivier Clerk-Lamalice, MD, MSc, FRCPC, FIPP
Research Sponsored by ReGelTec, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 12 and 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new gel injection treatment for people with severe back pain from worn-out spinal discs. It aims to help those who haven't gotten better with other treatments by cushioning the damaged areas in their spine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, 12 and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 12 and 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Success
Secondary study objectives
Back pain as measured by NRS
Function as measured by ODI
Safety of the ReGelTec Implant by demonstrating durability over the long term and no unanticipated safety concerns that arise
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: HYDRAFIL ImplantExperimental Treatment1 Intervention
Polymer Implant of HYDRAFIL into a one or two lumbar intervertebral discs
Who is running the clinical trial?
ReGelTec, Inc.Lead Sponsor
1 Previous Clinical Trials
225 Total Patients Enrolled
Olivier Clerk-Lamalice, MD, MSc, FRCPC, FIPPPrincipal InvestigatorBeam Interventional & Diagnostic Imaging
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe compression on your cauda equina, which is the bundle of nerves at the lower end of your spinal cord.You are 22 to 80 years old.You have disc degeneration on MRI with at least one level of disc height loss.You are legally competent and able to understand the nature, scope and aim of the clinical investigation.You have been experiencing lower back pain and other symptoms of degenerative disc disease in your lower spine for at least six months.Your symptoms have not improved after trying pain medication and/or physical therapy for 12 weeks.You have had or currently have an infection in your whole body or in a specific area.You have a serious condition called severe osteoporosis or metabolic bone disease.You have a history of alcohol or drug abuse, or are currently using alcohol or drugs in a way that is harmful or addictive.You have tumors in your spine that are currently growing or causing symptoms.You are allergic or sensitive to the materials used in the implant.You have severe back pain that rates at least 4 out of 10 on a scale, and it impacts your ability to do daily activities, which is measured by the Oswestry Disability Index score of at least 30.You have certain spine conditions like spondylolysis, spondylolisthesis, spinal canal stenosis, or scoliosis with a Cobb angle greater than 20 degrees. These conditions could affect your ability to participate in the study.You have specific types of spine disc herniations or Schmorl's nodes.You have a condition called neurogenic claudication caused by spinal stenosis.You have a condition called arachnoiditis.You have lower back pain that is caused by something other than issues with your spine, or the cause of your lower back pain is unknown.You have been experiencing lower back pain and symptoms of degenerative disc disease in your lower spine for at least 6 months.Your symptoms did not improve or get better after trying pain medication and/or physical therapy for 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: HYDRAFIL Implant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Degenerative Disc Disease Patient Testimony for trial: Trial Name: NCT04984629 — N/A
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