Actively Recruiting

Phase Not Applicable
Age: 22Years - 85Years
All Genders
NCT06011551

HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

Led by ReGelTec, Inc. · Updated on 2026-05-08

225

Participants Needed

14

Research Sites

198 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

Who Can Participate

Age: 22Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female subjects aged 22 to 85 years, inclusive
  • Chronic low back pain greater than leg pain with symptoms of degenerative disc disease in the lumbar region for at least 6 months
  • Presence of one or two symptomatic lumbar discs confirmed by discography
  • Symptomatic discs showing Grade 4 to 8 degeneration on MRI (modified Pfirrmann scale)
  • Failure to improve after at least 6 months of conservative care including physical therapy and/or pain medication
  • Psychosocially, mentally, and physically able and willing to comply with study requirements and follow-up
  • Fluent in English
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • History or presence of systemic or local infection
  • Skin disease or inadequate tissue at the injection site
  • Annular tear or defect with 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
  • Large annular fissures with disc protrusions at symptomatic levels
  • Steroid, intradiscal, trigger point, facet, or medial branch injections within 60 days before enrollment
  • Opioid use over 60 MME/day or increase within 60 days before enrollment
  • Modic type 3 changes
  • Radicular pain greater than back pain in last 6 months, excluding somatic referred pain
  • Neurogenic claudication due to spinal stenosis
  • Prior lumbar spine surgery
  • History of lumbar vertebral fractures
  • Severe cauda equina compression
  • Spinal instability, severe canal stenosis, isthmus pathology, or scoliosis with Cobb angle >20
  • Arachnoiditis
  • Prisoners or wards of courts
  • Active litigation or worker's compensation cases
  • Chronic anticoagulation that cannot be safely stopped or anticoagulant use within 3 days prior to procedure
  • Low back pain of non-spinal or unknown cause
  • Substance abuse or chemical dependency history within 5 years or current abuse
  • Major psychiatric disorders such as major depression, bipolar disorder, or schizophrenia
  • Pregnant or trying to become pregnant females
  • Inability to understand consent or comply with follow-up
  • Participation in other clinical studies within 3 months or planned during this trial
  • Body Mass Index over 35 kg/m2
  • Current smoker or tobacco/nicotine user
  • Allergy or sensitivity to device materials
  • Endocrine or metabolic disorders affecting bone growth
  • Insulin-dependent diabetes mellitus
  • Inability to undergo required imaging or discography
  • Medical conditions making participation unsafe or assessments unreliable
  • Active or residual malignancy
  • Degenerative or neurological conditions interfering with outcomes or increasing risk
  • Chronic or acute kidney or liver impairment
  • Severe osteoporosis as defined by specific imaging criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 14 locations

1

Alabama Clinical Therapeutics

Birmingham, Alabama, United States, 35235

Actively Recruiting

2

Source Healthcare

Santa Monica, California, United States, 90403

Actively Recruiting

3

Boomerang Healthcare (IPM Medical Group)

Walnut Creek, California, United States, 94598

Actively Recruiting

4

DBPS Research (The Denver Spine & Pain Institute)

Greenwood Village, Colorado, United States, 80111

Actively Recruiting

5

The Orthopaedic Institute

Gainesville, Florida, United States, 32607

Actively Recruiting

6

Southwest Florida Pain Center

Port Charlotte, Florida, United States, 33948

Actively Recruiting

7

NRSA Group (Florida Spine & Pain Specialists)

Riverview, Florida, United States, 33569

Actively Recruiting

8

Horizon Clinical Research (Southern Pain and Spine)

Jasper, Georgia, United States, 30143

Actively Recruiting

9

Neuroscience Research Center, LLC

Overland Park, Kansas, United States, 66210

Actively Recruiting

10

Spine Institute of Louisiana (The Spine Network)

Shreveport, Louisiana, United States, 71101

Actively Recruiting

11

Clinical Investigations

Edmond, Oklahoma, United States, 73103

Actively Recruiting

12

Precision Spine Care

Tyler, Texas, United States, 75701

Actively Recruiting

13

Virginia iSpine Physicians

Richmond, Virginia, United States, 23238

Actively Recruiting

14

Beam Research (Beam Radiology)

Calgary, Alberta, Canada, T3R 0N2

Actively Recruiting

Loading map...

Research Team

S

Seth Kaufman

CONTACT

E

Elisa B Storyk, MPH, CCRP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here