HYDRAFIL for Back Pain Due to Degenerative Disc Disease
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment HYDRAFIL for back pain due to degenerative disc disease?
Research on intradiscal hydrogel treatments, like GelStix, shows they can help reduce back pain in patients with degenerative disc disease who haven't responded to other treatments. This suggests that HYDRAFIL, a similar hydrogel treatment, might also be effective for back pain caused by this condition.12345
How is the treatment HYDRAFIL different from other treatments for degenerative disc disease?
HYDRAFIL is unique because it involves the injection of a hydrogel into the intervertebral disc, which acts as a reservoir of hydration to increase pressure and improve pH balance, potentially preserving the disc. This approach is different from traditional treatments like surgery or conservative management, as it aims to regenerate and maintain the disc's health.13678
Research Team
Olivier Clerk-Lamalice, MD, MSc, FRCPC, FIPP
Principal Investigator
Beam Interventional & Diagnostic Imaging
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Polymer Implant of HYDRAFIL into one or two lumbar intervertebral discs
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- HYDRAFIL
Find a Clinic Near You
Who Is Running the Clinical Trial?
ReGelTec, Inc.
Lead Sponsor