Recruiting

Hydrogel

Sponsor:

ReGelTec, Inc.

Code:

NCT06011551

Conditions

Degenerative Disc Disease (DDD)

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

The ReGelTec HYDRAFIL™ System

Conservative Care Management

Study Details

Brief summary:

A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.

Conditions

Degenerative Disc Disease (DDD)

Study ID

NCT06011551

Start date

Jan 13, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

225 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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")

sham comparator: 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")

other: Crossover After 24M for Control Patient if Qualified

Study design includes a crossover for control arm after 24 months if qualified after a screening evaluation

Interventions

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)

Primary outcome measure

  • Composite Endpoint of Clinical Success [ Time Frame: 12-month ]

Central Contacts and Locations

Central contacts

Seth Kaufman

443-451-3915

Elisa B Storyk, MPH, CCRP

443-451-3915

Locations

Alabama Clinical Therapeutics

Recruiting

Birmingham, Alabama, United States, 35235

Principal Investigator:

Bradly Goodman, MD

Source Healthcare

Recruiting

Santa Monica, California, United States, 90403

Principal Investigator:

Timothy Davis, MD

Boomerang Healthcare (IPM Medical Group)

Recruiting

Walnut Creek, California, United States, 94598

Principal Investigator:

Kasra Amirdelfan, MD

DBPS Research (The Denver Spine & Pain Institute)

Recruiting

Greenwood Village, Colorado, United States, 80111

Principal Investigator:

J. Scott Bainbridge, MD

The Orthopaedic Institute

Recruiting

Gainesville, Florida, United States, 32607

Principal Investigator:

Ajay Antony, MD

Southwest Florida Pain Center

Recruiting

Port Charlotte, Florida, United States, 33948

Principal Investigator:

Robert Ball, DO, MS

NRSA Group (Florida Spine & Pain Specialists)

Recruiting

Riverview, Florida, United States, 33569

Principal Investigator:

Nomen Azeem, MD, FAAPMR

Tenet Florida Physician Services II (Cantor Spine Center at The Paley Orthopedic and Spine Institute)

Recruiting

West Palm Beach, Florida, United States, 33407

Principal Investigator:

Benjamin Westerhaus, MD

Horizon Clinical Research (Southern Pain and Spine)

Recruiting

Jasper, Georgia, United States, 30143

Principal Investigator:

Jordan L. Tate, MD, MPH

Neuroscience Research Center, LLC

Recruiting

Overland Park, Kansas, United States, 66210

Principal Investigator:

Mayank Gupta, MD

Spine Institute of Louisiana (The Spine Network)

Recruiting

Shreveport, Louisiana, United States, 71101

Principal Investigator:

Pierce Nunley, MD

Clinical Investigations

Recruiting

Edmond, Oklahoma, United States, 73103

Principal Investigator:

Douglas Beall, MD

Precision Spine Care

Recruiting

Tyler, Texas, United States, 75701

Principal Investigator:

Aaron Calodney, MD

Virginia iSpine Physicians

Recruiting

Richmond, Virginia, United States, 23238

Principal Investigator:

Michael J. DePalma, MD

Beam Research (Beam Radiology)

Recruiting

Calgary, Alberta, Canada, T3R 0N2

Principal Investigator:

Olivier Clerk, MD, MSc, FRCPC, FIPP

More Information

Sponsor

ReGelTec, Inc.

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • Intervertebral Disc
  • Nucleus Pulposus
  • Disc Augmentation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ReGelTec, Inc. on 2026-07-30.