What is the ReGelTec HYDRAFIL System studying for degenerative disc disease?

The ReGelTec HYDRAFIL System is being studied to evaluate its safety and effectiveness in treating chronic low back pain caused by degenerative disc disease. Researchers want to determine if delivering a hydrogel implant to lumbar discs helps reduce severe pain and improve function. The study is sponsored by ReGelTec, Inc. and aims to provide important insights for patients with this condition.

Who may be eligible for this degenerative disc disease clinical trial?

Adults aged 22 to 85 years with chronic low back pain due to degenerative disc disease lasting at least six months may be eligible. Both men and women can participate if they have one or two symptomatic lumbar discs confirmed by discography and have tried conservative care without adequate relief. Please review eligibility criteria for more details.

Is there any cost to participate in this degenerative disc disease clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional expenses related to their participation.

Actively Recruiting

Phase Not Applicable

Age: 22Years - 85Years

All Genders

ID06011551

Study of the ReGelTec HYDRAFIL System for Treating Chronic Low Back Pain from Degenerative Lumbar Discs Randomized Trial Comparing Hydrogel Implant with Conservative Care

Led by ReGelTec, Inc. · Updated on 2026-07-30

225

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the ReGelTec HYDRAFIL System for adults with axial chronic low back pain caused by degenerative disc disease DDD. This study focuses on participants who continue to experience severe back pain and dysfunction after at least six months of non-surgical conservative care. The trial is a multicenter, prospective, dual-arm, randomized controlled pivotal study designed to provide important data on this treatment device. Participants are divided into two groups one group receives continued conservative medical management plus a percutaneous hydrogel spinal implant delivered by the HYDRAFIL System, while the other group continues conservative care with a sham procedure involving needle insertion without implant delivery. After 24 months, participants in the control group may crossover to receive the hydrogel implant if they qualify. The study involves delivering an injectable hydrogel implant to the lumbar discs to address degeneration. During the study, participants will be monitored regularly and assessed for clinical success, including symptom improvement over a 12-month period. Evaluations will include imaging and clinical assessments to measure outcomes. Participants must comply with follow-up schedules and complete required forms. The total study duration extends through 2028, allowing long-term observation of safety and effectiveness.

CONDITIONS

Brief Title

HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

Who Can Participate

Age: 22Years - 85Years

All Genders

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 of the lumbar region lasting at least six months
Presence of one or two symptomatic lumbar discs confirmed by Discography
Symptomatic discs showing Grade 4 to 8 degeneration on MRI using the modified Pfirrmann scale
Persistent symptoms despite at least six months of conservative care
Psychosocially, mentally and physically able and willing to comply with the study protocol, including follow-up visits and forms
Fluent in English
Signed informed consent

You will not qualify if you...

Active systemic or local infection
Skin disease or inadequate tissue coverage at the injection site
Annular tear or defect with free 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
Epidural steroid, intradiscal, trigger point, facet, or medial branch injection within 60 days prior to randomization
Opioid use over 60 MME/day or increased opioid use within 60 days prior to randomization
Modic type 3 changes at symptomatic or adjacent levels
Nerve pain greater than back pain in last six months with nerve compression on imaging
Neurogenic claudication due to spinal stenosis
Prior lumbar spine surgery except certain non-instrumented procedures completed over one year ago without symptom recurrence
History of vertebral fractures in lumbar spine
Severe compression of cauda equina
Spinal instability, severe canal stenosis, isthmus pathology, or scoliosis with Cobb angle over 20
Arachnoiditis
Prisoners or wards of courts
Active litigation including worker's compensation cases
Chronic anticoagulation that cannot be safely stopped or anticoagulants taken within three days prior to procedure
Low back pain of non-spinal or unknown cause
Substance abuse or chemical dependency within last five years or current abuse
Major psychiatric disorders such as major depression, bipolar disorder, or schizophrenia
Pregnant or trying to become pregnant during trial
Inability to understand consent or unwillingness to follow protocol
Participation in other clinical trials within last three months or planned during this trial
Body mass index over 40 kg/m2
Allergy or hypersensitivity to device materials
Endocrine or metabolic disorders affecting bone growth
Insulin-dependent diabetes mellitus
Inability to undergo required imaging or assessments
Medical conditions interfering with safety or effectiveness evaluation
Active or residual malignancy
Degenerative or neurological conditions increasing risk of failure or complications
Chronic or acute renal or liver impairment
Severe osteoporosis confirmed by DEXA or QCT scans

Research Team

Seth Kaufman

Elisa B Storyk, MPH, CCRP

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Study of the ReGelTec HYDRAFIL System for Treating Chronic Low Back Pain from Degenerative Lumbar Discs Randomized Trial Comparing Hydrogel Implant with Conservative Care

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria