NCT06011551

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Jan 2025

Longer than P75 for not_applicable

Geographic Reach
2 countries

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Jan 2025Nov 2028

First Submitted

Initial submission to the registry

August 21, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 13, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

August 21, 2023

Last Update Submit

January 30, 2026

Conditions

Degenerative Disc Disease (DDD)

Keywords

Intervertebral DiscNucleus PulposusDisc Augmentation

Outcome Measures

Primary Outcomes (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.

    12-month

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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")

Device: The ReGelTec HYDRAFIL™ SystemOther: Conservative Care Management

Control Arm

SHAM COMPARATOR

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: Conservative Care Management

Interventions

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.

Treatment Arm
Conservative Care ManagementOTHER

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

Also known as: Non-surgical conservative medical management
Control ArmTreatment Arm

Eligibility Criteria

Age22 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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 \[Cobb angle \>20 at the index level(s)\]
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

RECRUITING

Source Healthcare

Santa Monica, California, 90403, United States

RECRUITING

Boomerang Healthcare (IPM Medical Group)

Walnut Creek, California, 94598, United States

RECRUITING

DBPS Research (The Denver Spine & Pain Institute)

Greenwood Village, Colorado, 80111, United States

RECRUITING

Southwest Florida Pain Center

Port Charlotte, Florida, 33948, United States

RECRUITING

NRSA Group (Florida Spine & Pain Specialists)

Riverview, Florida, 33569, United States

RECRUITING

Horizon Clinical Research (Southern Pain and Spine)

Jasper, Georgia, 30143, United States

RECRUITING

Spine Institute of Louisiana (The Spine Network)

Shreveport, Louisiana, 71101, United States

RECRUITING

Clinical Investigations

Edmond, Oklahoma, 73103, United States

RECRUITING

Precision Spine Care

Tyler, Texas, 75701, United States

RECRUITING

Virginia iSpine Physicians

Richmond, Virginia, 23238, United States

RECRUITING

Beam Research (Beam Radiology)

Calgary, Alberta, T3R 0N2, Canada

RECRUITING

Related Links

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Douglas Beall, MD

    Clinical Investigations LLC

    PRINCIPAL INVESTIGATOR

  • Kasra Amirdelfan, MD

    IPM Medical Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seth Kaufman

CONTACT

443-451-3915

Elisa B Storyk, MPH, CCRP

CONTACT

443-451-3915

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single-blind (participants will be blinded to treatment assignment)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, dual arm, randomized, controlled pivotal study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

August 25, 2023

Study Start

January 13, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(11)CA(1)