Study of the ReGelTec HYDRAFIL System

NCT04984629 | Completed DMC

• 1 other identifier: RGOUS -1000CAN
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

A study designed to treat patients with back pain associated with degenerative lumbar disc disease.

Conditions

Degenerative Disc Disease

Keywords

DDD; Degenerative Disc Disease; Back Pain; Lumbar Pain

Outcome Measures

Primary Outcomes (1)

• Success

  Successful implantation of the ReGelTec HYDRAFIL System implant in a lumbar disc nucleus

  post-treatment

Secondary Outcomes (3)

• Back pain as measured by NRS

  3, 6, 12 and 24 months

• Function as measured by ODI

  3, 6, 12 and 24 months

• Safety of the ReGelTec Implant by demonstrating durability over the long term and no unanticipated safety concerns that arise

  3, 6, 12 and 24 months

Study Arms (1)

HYDRAFIL Implant

EXPERIMENTAL

Polymer Implant of HYDRAFIL into a one or two lumbar intervertebral discs

Device: HYDRAFIL

Interventions

HYDRAFIL DEVICE

The HYDRAFIL System contains the following items: the Delivery System and the Pressure Gauge. The HYDRAFIL implant is contained within a pre-filled syringe that is inserted into the delivery system housing during the manufacturing process. The implant is heated within the delivery system prior to use to ensure a flowable implant that can be injected through a standard coaxial needle.

HYDRAFIL Implant

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Present with predominant low back pain and symptoms of DDD of the lumbar region of at least 6 months duration
• Failure to have their symptoms resolve or reduce following 6 months conservative care (pain medication and/or physical therapy)
• Male or female patients aged 22 to 80 years, inclusive
• Presence of DDD on magnetic resonance imaging (MRI) scan with global disc degeneration. Modified Pfirrmann grades 5 to 8 as characterized by MRI
• The presence of one or two symptomatic discs exhibiting degeneration contained within a competent outer annulus as determined by MRI and provocative discography and/or anaesthetic discography at L1-S1
• Patients who are legally competent and able to understand the nature, scope and aim of the clinical investigation
• Signed an informed subject consent form in a language in which they are fluent

You may not qualify if:

• History of or current systemic or local infection
• Annular tear or defect that shows free contrast extravasation into the epidural space during or after discography
• Presence of disc herniation that accounts for the majority of the patient's symptoms
• Subjects with Modic type 3 changes
• Subjects with trans-endplate disc herniations or Schmorl's nodes
• Neurogenic claudication due to spinal stenosis
• Previous back surgery at the target level of the lumbar spine
• Evidence of severe compression of cauda equina
• Spinal segmental instability (spondylolysis or spondylolisthesis: Grade \>1), spinal canal stenosis, isthmus pathology, scoliosis \[Cobb angle \>20 at the incident level\] and other deformity conditions that may compromise the study
• Subjects with arachnoiditis
• Subjects who are prisoners or wards of the courts
• Subjects involved in active litigation including worker's compensation cases
• Subjects with low back pain of non-spinal or unknown etiology
• Subjects with severe osteoporosis or metabolic bone disease
• Subjects who have a history of or are current abusers of alcohol or drugs (using definition criteria from the Diagnostic and Statistical Manual of Mental Disorders (DSM-V))

Sponsors & Collaborators

• ReGelTec, Inc.: lead

Study Sites (1)

Beam Interventional & Diagnostic Imaging

Calgary, Alberta, T3K6G4, Canada

Location

Related Links

• Sponsor Website

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Back Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Olivier Clerk-Lamalice, MD, MSc, FRCPC, FIPP

  Beam Interventional & Diagnostic Imaging

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will receive the HYDRAFIL implant

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 30, 2021
• Study Start: January 4, 2022
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)