HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

This study is testing a new treatment called the ReGelTec HYDRAFIL™ System for people with chronic low back pain due to degenerative disc disease (DDD). DDD is when the discs between your spinal bones wear down. The HYDRAFIL System uses an injectable gel implant. This study will compare the HYDRAFIL System to standard care, which includes physical therapy and/or pain medication. Researchers want to see if the HYDRAFIL System is safe and effective. You may be able to join if you are between 22 and 85 years old, have had low back pain for at least six months, and have one or two symptomatic discs. The study aims to enroll 225 participants and is currently unclear about its recruitment status. Success will be measured at 12 months.

Study design: This is a multi-center, prospective study that will randomly assign participants to either the ReGelTec HYDRAFIL™ System or conservative care management. The study plans to enroll 225 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint for measuring success is at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

Recruiting

NAAges 22–85InterventionalTreatment

ReGelTec, Inc.

~225 participants

Updated 2026-09-14 on ClinicalTrials.gov

What's tested:The ReGelTec HYDRAFIL™ SystemConservative Care Management

At a glance

Recruiting sites

15 of 16 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Composite Endpoint of Clinical Success

Measured over 12-month

Conditions

Degenerative Disc Disease (DDD)

NCT06011551

Where you'd take part

This study runs at 16 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Alabama Clinical Therapeutics
Birmingham, Alabamano site contact published
Recruiting
Beam Research (Beam Radiology)
Calgary, Alberta, Canadano site contact published
Recruiting
Boomerang Healthcare (IPM Medical Group)
Walnut Creek, Californiano site contact published
Recruiting
Clinical Investigations
Edmond, Oklahomano site contact published
Recruiting
DBPS Research (The Denver Spine & Pain Institute)
Greenwood Village, Coloradono site contact published
Recruiting
Horizon Clinical Research (Southern Pain and Spine)
Jasper, Georgiano site contact published
Recruiting
International Spine, Pain & Performance Center and Mountain Spine & Pain
Washington D.C., District of Columbiano site contact published
Not yet recruiting
Neuroscience Research Center, LLC
Overland Park, Kansasno site contact published
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Douglas Beall, MD · PRINCIPAL_INVESTIGATOR · Clinical Investigations LLC
Kasra Amirdelfan, MD · PRINCIPAL_INVESTIGATOR · IPM Medical Group

Who to contact

Seth Kaufman

443-451-3915 · ext. 107

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Eligibility criteria

Inclusion

Male or female subjects aged 22 to 85 years, inclusive

Subjects presenting with LBP greater than leg pain and symptoms of DDD of the lumbar region (L1- S1) of at least six (6) months duration

Presence of one (1) or two (2) symptomatic disc(s) (i.e., only 1-level or 2-levels may be treated during the study) as determined by Discography

Symptomatic disc(s) exhibiting Grade 4 to 8 degeneration on the modified Pfirrmann scale as determined by MRI

Failure to have their symptoms resolve or reduce following at least six (6) months of conservative care (as defined in the body of the protocol)

Psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms

English fluency

Signed informed consent

Exclusion

Active systemic or local infection

Any skin disease or inadequate tissue coverage at the site of the proposed injection

Annular tear or defect that shows free contrast extravasation into the epidural space during or after Discography

Presence of more than two (2) symptomatic discs presenting with pain confirmed during Discography

Presence of extruded or sequestered disc herniation (i.e., disc extrusions or sequestrations) at the symptomatic level(s) or on adjacent levels

Presence of wide annular fissures confluent with large disc protrusions at the symptomatic level(s)

Epidural steroid injection, intradiscal injection, trigger point injection, facet or medial branch block within 60 days of randomization

Opioid medication usage \>60 MME (morphine milligram equivalent)/day or increase in opioid use within 60 days of randomization

Evidence of Modic type 3 changes at the symptomatic level(s) or on adjacent levels

Subjects presenting with nerve pain following a dermatomal distribution and that correlates with nerve compression on imaging where lower limb pain is greater than back pain or by history within the past six (6) months. Note: somatic referred pain is allowed

Evidence of neurogenic claudication due to spinal stenosis

Subjects having had any prior lumbar spine surgery (instrumented or non-instrumented) except: a. A non-instrumented procedure not at the symptomatic or adjacent levels (i.e., discectomy, laminectomy, MILD procedure) is not exclusionary if the procedure was completed at least one (1) year or greater from randomization with complete resolution of treated symptoms and no recurrence

History of vertebral fractures in the lumbar spine

Evidence of severe compression of cauda equina

Evidence of spinal segmental instability (spondylolysis or spondylolisthesis: Grade \>1), severe spinal canal stenosis, isthmus pathology, or scoliosis \[Cobb angle \>20 at the index level(s)\]

Subjects with arachnoiditis

Subjects who are prisoners or wards of courts

Subjects involved in active litigation including worker's compensation cases

Subjects on chronic anticoagulation due to a bleeding disorder and unable to safely stop anticoagulants, or has taken anticoagulants within three (3) days prior to procedure

Subjects with LBP of non-spinal or unknown etiology

Subjects who have a history (in the last five (5) years) of substance abuse or chemical dependency (pharmaceuticals, illicit drugs, alcohol) or are current abusers (using definition criteria from the Diagnostic and Statistical Manual of Mental Disorders (DSM-V))

Subjects who have major psychiatric disorders, such as major depression, bipolar disorder and schizophrenia, as defined by the DSM-V

If female, subjects 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 inability or unwillingness to adhere to the study follow-up visit schedule or other protocol requirements

Subjects who have participated in any other clinical study within the last three (3) months that, in the opinion of the investigator, could bias the results of the HYDRAFIL-D study, or subjects that are actively participating in any other clinical study, or have planned participation in any other clinical study during the course of this trial. Note: subjects must agree they will not participate in any other clinical study during the course of this trial

Body Mass Index (BMI) \>40 kg/m2

Known allergy or hypersensitivity to any of the device materials

Endocrine or metabolic disorder known to affect osteogenesis

Insulin-dependent diabetes mellitus

Inability to undergo X-ray, MRI, CT scans or other radiographic assessments, including Discography

Any comorbid medical condition which, in the best judgement of the Investigator, would make the subject unsuitable for inclusion in the study or interferes with the proper assessment of safety or effectiveness (e.g., systemic disease)

Subjects with any active malignancy or who have been previously diagnosed with a malignancy and have evidence of residual disease

Any degenerative or neurological condition that would interfere with evaluation of outcomes or that may generate an unacceptable risk of failure or postoperative complications

Chronic or acute renal and/ or hepatic impairment

Evidence of severe osteoporosis. The SCORE/MORES will be utilized to screen if a DEXA scan is indicated. If SCORE/MORES value ≥ 6; then a DEXA scan is required. Severe osteoporosis is defined as DEXA T-score \< -2.5 (spine or hip) or QCT T-score \< 80mg/cubic cm

What this trial measures

Composite Endpoint of Clinical Success12-month
The primary endpoint is a single composite endpoint reflecting five study outcomes (function, SAEs, SSIs, intercurrent events, and radiographic findings). The individual subject's outcome will be considered a success if all of the criteria are met at 12 months.

Trialytics