HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs
NCT ID: NCT06011551
Last Updated: 2026-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
225 participants
INTERVENTIONAL
2025-01-13
2028-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment Arm
Group A: continued non-surgical conservative medical management plus a percutaneous hydrogel spinal implant delivered via the HYDRAFIL System (the HYDRAFIL implant) (the "Treatment Arm")
The ReGelTec HYDRAFIL™ System
The ReGelTec HYDRAFIL System is designed to deliver an injectable hydrogel implant (the HYDRAFIL implant) for the treatment of a degenerative lumbar disc.
Conservative Care Management
Conservative care management (including physical therapy and/or pain medication)
Control Arm
Group B: continued non-surgical conservative medical management plus advancement of the HYDRAFIL System delivery needle to inside the skin in the direction of the target disc(s) but without contacting the muscle layer or deeper (the "Control Arm")
Conservative Care Management
Conservative care management (including physical therapy and/or pain medication)
Interventions
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The ReGelTec HYDRAFIL™ System
The ReGelTec HYDRAFIL System is designed to deliver an injectable hydrogel implant (the HYDRAFIL implant) for the treatment of a degenerative lumbar disc.
Conservative Care Management
Conservative care management (including physical therapy and/or pain medication)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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 enrollment
* Opioid medication usage \>60 MME (morphine milligram equivalent)/day or increase in opioid use within 60 days of enrollment
* Evidence of Modic type 3 changes
* Subjects presenting with radicular pain greater than back pain or by history within the past six (6) months. Radicular pain is defined as nerve pain following a dermatomal distribution and that correlates with nerve compression on imaging. Note: somatic referred pain is allowed
* Evidence of neurogenic claudication due to spinal stenosis
* Subjects with any prior back surgery on the lumbar spine
* 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 having participated in any other clinical study within the last three (3) months, or 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) \>35 kg/m2
* Current smoker or nicotine and/or tobacco user
* 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 SCORES/MORES will be utilized to screen if a DEXA scan is indicated. If SCORES/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
22 Years
85 Years
ALL
No
Sponsors
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ReGelTec, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Douglas Beall, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Investigations LLC
Kasra Amirdelfan, MD
Role: PRINCIPAL_INVESTIGATOR
IPM Medical Group
Locations
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Alabama Clinical Therapeutics
Birmingham, Alabama, United States
Source Healthcare
Santa Monica, California, United States
Boomerang Healthcare (IPM Medical Group)
Walnut Creek, California, United States
DBPS Research (The Denver Spine & Pain Institute)
Greenwood Village, Colorado, United States
Southwest Florida Pain Center
Port Charlotte, Florida, United States
NRSA Group (Florida Spine & Pain Specialists)
Riverview, Florida, United States
Horizon Clinical Research (Southern Pain and Spine)
Jasper, Georgia, United States
Spine Institute of Louisiana (The Spine Network)
Shreveport, Louisiana, United States
Clinical Investigations
Edmond, Oklahoma, United States
Precision Spine Care
Tyler, Texas, United States
Virginia iSpine Physicians
Richmond, Virginia, United States
Beam Research (Beam Radiology)
Calgary, Alberta, Canada
Countries
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Central Contacts
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Seth Kaufman
Role: CONTACT
Elisa B Storyk, MPH, CCRP
Role: CONTACT
Facility Contacts
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Jill Andringa, RN
Role: primary
Gabriel Wirnowski
Role: primary
Owen Kao
Role: backup
Mulan McNabb
Role: primary
Josephine Kubik
Role: primary
Marie Zambelli, APRN-FNP
Role: primary
Rachel Gelch
Role: primary
Julianna Kirby
Role: primary
Krista Kachnik, BS, ACRP-CP
Role: primary
Jennifer Witherby, BSN, RN
Role: primary
Jessica Youngblood
Role: primary
Devon Withers
Role: primary
Kimberly Carcary, MSc
Role: primary
Related Links
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Sponsor Company Website
HYDRAFIL-D Study Website
Other Identifiers
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RGT-2000PS
Identifier Type: -
Identifier Source: org_study_id
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