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Degenerative Disc Disease (DDD)HYDRAFIL-DNCT06011551

HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

A study testing The ReGelTec HYDRAFIL™ System and Conservative Care Management in people with Degenerative Disc Disease (DDD), run by ReGelTec, Inc. at 16 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 22 to 85 years
Conditions the study is for
Degenerative Disc Disease (DDD)
What is being tested?
The ReGelTec HYDRAFIL™ System and Conservative Care Management
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
225 participants
Where
16 sitesin 2 countries
Study dates
13 Jan 2025to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 35Show fewer
  • 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

Trial locations and contacts

16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Seth Kaufman contact

443-451-3915 ext. 107

Elisa B Storyk, MPH, CCRP contact

443-451-3915

16 sites in 2 countries

United States15 sites, 14 recruiting

  • Alabama Clinical Therapeutics

    Birmingham, Alabama, 35235

    Jill Andringa, RN

    Bradly Goodman, MD

    Recruiting

  • Clinical Investigations

    Edmond, Oklahoma, 73103

    Jennifer Witherby, BSN, RN

    Douglas Beall, MD

    Recruiting

  • The Orthopaedic Institute

    Gainesville, Florida, 32607

    Aldrin Yumul

    Ajay Antony, MD

    Recruiting

  • DBPS Research (The Denver Spine & Pain Institute)

    Greenwood Village, Colorado, 80111

    Josephine Kubik

    Jake Feller

    Recruiting

  • Horizon Clinical Research (Southern Pain and Spine)

    Jasper, Georgia, 30143

    Julianna Kirby

    Jordan L. Tate, MD, MPH

    Recruiting

  • Neuroscience Research Center, LLC

    Overland Park, Kansas, 66210

    Amy Reinert, BS

    Mayank Gupta, MD

    Recruiting

  • Southwest Florida Pain Center

    Port Charlotte, Florida, 33948

    Marie Zambelli, APRN-FNP

    Robert Ball, DO, MS

    Recruiting

  • Virginia iSpine Physicians

    Richmond, Virginia, 23238

    Devon Withers

    Jack Davis

    Recruiting

  • NRSA Group (Florida Spine & Pain Specialists)

    Riverview, Florida, 33569

    Rachel Gelch

    Nomen Azeem, MD, FAAPMR

    Recruiting

  • Source Healthcare

    Santa Monica, California, 90403

    Shannon Zhu

    Nidhi Thati

    Recruiting

  • Spine Institute of Louisiana (The Spine Network)

    Shreveport, Louisiana, 71101

    Krista Kachnik, BS, ACRP-CP

    Pierce Nunley, MD

    Recruiting

  • Precision Spine Care

    Tyler, Texas, 75701

    Alain Sayegh

    Aaron Calodney, MD

    Recruiting

  • Boomerang Healthcare (IPM Medical Group)

    Walnut Creek, California, 94598

    Kat Abtahi

    Shari Mae Santa Ana

    Recruiting

  • International Spine, Pain & Performance Center and Mountain Spine & Pain

    Washington D.C., District of Columbia, 20006

    Active, not recruiting

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

    West Palm Beach, Florida, 33407

    Rebecca Nembhard, CCRP

    Benjamin Westerhaus, MD

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • Beam Research (Beam Radiology)

    Calgary, Alberta, T3R 0N2

    Kimberly Carcary, MSc

    Olivier Clerk, MD, MSc, FRCPC, FIPP

    Recruiting

Other trials in Canada

About this study

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

Read the detailed description

This pivotal study is designed to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL System in subjects with axial chronic low back pain (CLBP) due to degenerative disc disease (DDD) who continue to have severe back pain and dysfunction after at least six (6) months of conservative care.

Being tested
The ReGelTec HYDRAFIL™ System, Conservative Care Management
Keywords
Intervertebral Disc, Nucleus Pulposus, Disc Augmentation
Medical subject headings
Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The ReGelTec HYDRAFIL™ SystemDevice

    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 ManagementOther

    Also called Non-surgical conservative medical management

    Conservative care management (including physical therapy and/or pain medication)

Study groups in NCT06011551
Study groupRoleWhat they receive
Treatment ArmExperimentalGroup A: continued non-surgical conservative medical management plus a percutaneous hydrogel spinal implant delivered via the HYDRAFIL System (the HYDRAFIL implant) (the "Treatment Arm")
Receives: Device: The ReGelTec HYDRAFIL™ System; Other: Conservative Care Management
Control ArmSham comparatorGroup 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")
Receives: Other: Conservative Care Management
Crossover After 24M for Control Patient if QualifiedOtherStudy design includes a crossover for control arm after 24 months if qualified after a screening evaluation
Receives: Device: The ReGelTec HYDRAFIL™ System; Other: Conservative Care Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite Endpoint of Clinical Success

    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.

    Measured: 12-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2023
  2. Study start13 Jan 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, dual arm, randomized, controlled pivotal study
Masking
Single blind
Who is masked
Participant
Enrolment
225 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06011551
Sponsor's protocol ID
RGT-2000PS
Acronym
HYDRAFIL-D
Status last verified
Sep 2026
First submitted
21 Aug 2023
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing The ReGelTec HYDRAFIL™ System and Conservative Care Management in people with Degenerative Disc Disease (DDD), run by ReGelTec, Inc. at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Seth Kaufman (443-451-3915 ext. 107), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Endpoint of Clinical Success (time frame: 12-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06011551.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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