Actively Recruiting
HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs
Led by ReGelTec, Inc. · Updated on 2026-05-08
225
Participants Needed
14
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the ReGelTec HYDRAFIL System in adults aged 22 to 85 years who have axial chronic low back pain caused by degenerative disc disease (DDD). This condition must have persisted for at least six months despite conservative care. The study is a multi-center, prospective, randomized controlled trial designed to compare outcomes between two groups and provide pivotal data on this treatment approach. Participants will be randomly assigned to one of two groups. The treatment group will receive continuation of non-surgical conservative care along with a percutaneous hydrogel spinal implant delivered through the HYDRAFIL System. The control group will continue conservative care but will undergo a sham procedure where the delivery needle is advanced only to the skin without deeper insertion. The study will assess the impact of these interventions on the lumbar discs. Throughout the study, participants will be monitored for clinical success at 12 months using a composite endpoint. Researchers will collect data on pain, function, and safety, with follow-up visits to assess outcomes and adherence to study procedures. The total time commitment spans at least one year from treatment to final evaluation, ensuring detailed observation of the device’s performance and participant well-being.
CONDITIONS
Brief Title
HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 22 to 85 years, inclusive
- Chronic low back pain greater than leg pain due to degenerative disc disease (L1-S1) lasting at least 6 months
- Presence of one or two symptomatic lumbar discs as determined by Discography
- Symptomatic discs showing Grade 4 to 8 degeneration on MRI using the modified Pfirrmann scale
- Failure to improve symptoms after at least 6 months of conservative care including physical therapy or pain medication
- Psychosocially, mentally, and physically able and willing to comply with study protocol and follow-up
- Fluent in English
- Signed informed consent
You will not qualify if you...
- History of or active systemic or local infection
- Skin disease or inadequate tissue coverage at injection site
- Annular tear with contrast leakage into epidural space during or after Discography
- More than two symptomatic discs confirmed by Discography
- Extruded or sequestered disc herniation at symptomatic or adjacent levels
- Wide annular fissures with large disc protrusions at symptomatic levels
- Recent epidural steroid, intradiscal, trigger point, facet, or medial branch injections within 60 days
- Opioid use greater than 60 morphine milligram equivalents per day or increased use within 60 days
- Evidence of Modic type 3 changes
- Radicular pain greater than back pain or history of same within 6 months
- Neurogenic claudication due to spinal stenosis
- Prior lumbar spine surgery
- History of lumbar vertebral fractures
- Severe cauda equina compression
- Spinal instability, severe stenosis, isthmus pathology, or scoliosis with Cobb angle over 20
- Arachnoiditis
- Prisoners or wards of the court
- Active litigation including worker's compensation
- Chronic anticoagulation that cannot be safely stopped or recent anticoagulant use
- Low back pain of non-spinal or unknown cause
- History or current substance abuse or chemical dependency
- Major psychiatric disorders such as major depression, bipolar disorder, or schizophrenia
- Female subjects who are pregnant or trying to conceive during the trial
- Inability or unwillingness to adhere to protocol or follow-up
- Participation in any other clinical study within 3 months or planned participation during this trial
- Body mass index over 35 kg/m2
- Current smoker or tobacco user
- Known allergy to device materials
- Endocrine or metabolic disorders affecting bone growth
- Insulin-dependent diabetes mellitus
- Unable to undergo X-ray, MRI, CT, or Discography
- Medical conditions that interfere with safety or assessment
- Active or residual malignancy
- Neurological or degenerative conditions interfering with evaluation or increasing risk
- Chronic or acute kidney or liver impairment
- Severe osteoporosis as defined by specific bone density scores or tests
- SCORES/MORES values requiring DEXA scan with T-score below thresholds indicating severe osteoporosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate post-procedure period
Participants receive either a percutaneous hydrogel spinal implant delivered via the HYDRAFIL System or a sham procedure as part of their treatment for degenerative lumbar discs.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are followed after the procedure to monitor safety and treatment effectiveness.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 14 locations
1
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
Actively Recruiting
2
Source Healthcare
Santa Monica, California, United States, 90403
Actively Recruiting
3
Boomerang Healthcare (IPM Medical Group)
Walnut Creek, California, United States, 94598
Actively Recruiting
4
DBPS Research (The Denver Spine & Pain Institute)
Greenwood Village, Colorado, United States, 80111
Actively Recruiting
5
The Orthopaedic Institute
Gainesville, Florida, United States, 32607
Actively Recruiting
6
Southwest Florida Pain Center
Port Charlotte, Florida, United States, 33948
Actively Recruiting
7
NRSA Group (Florida Spine & Pain Specialists)
Riverview, Florida, United States, 33569
Actively Recruiting
8
Horizon Clinical Research (Southern Pain and Spine)
Jasper, Georgia, United States, 30143
Actively Recruiting
9
Neuroscience Research Center, LLC
Overland Park, Kansas, United States, 66210
Actively Recruiting
10
Spine Institute of Louisiana (The Spine Network)
Shreveport, Louisiana, United States, 71101
Actively Recruiting
11
Clinical Investigations
Edmond, Oklahoma, United States, 73103
Actively Recruiting
12
Precision Spine Care
Tyler, Texas, United States, 75701
Actively Recruiting
13
Virginia iSpine Physicians
Richmond, Virginia, United States, 23238
Actively Recruiting
14
Beam Research (Beam Radiology)
Calgary, Alberta, Canada, T3R 0N2
Actively Recruiting
Research Team
S
Seth Kaufman
E
Elisa B Storyk, MPH, CCRP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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