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HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs | Clinical Trials | Clareo Health

RECRUITINGNA

HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

NCT06011551•ReGelTec, Inc.

Summary

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

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.

Eligibility

Age

22 - 85 years

Sex

ALL

Healthy Volunteers

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

•History of or 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 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
+26 more criteria

Locations (12)

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

Key Dates

Start Date

January 13, 2025

Primary Completion Date

November 1, 2027

Completion Date

November 1, 2028

Last Updated

February 3, 2026

Enrollment

225

ESTIMATED participants

Conditions

Degenerative Disc Disease (DDD)

Interventions

The ReGelTec HYDRAFIL™ System

DEVICE

Conservative Care Management

OTHER

Contacts

Seth Kaufman

CONTACT

443-451-3915

Elisa B Storyk, MPH, CCRP

CONTACT

443-451-3915

Retro Comparison of Subsidence Following Interbody Devices in Lumbar Spine

NCT05536453

Degenerative Disc Disease (DDD)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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