Study of the ReGelTec HYDRAFIL System

Prospective, Single Arm, Non-randomized, Traditional Feasibility Study to Evaluate the Safety and Performance of the ReGelTec HYDRAFIL System

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

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: HYDRAFIL

Detailed Description

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

The primary objective of this study is to evaluate the safety and efficacy the HYDRAFIL System.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3K6G4
      • Beam Interventional & Diagnostic Imaging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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))
• If female, patients 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 participation in any other clinical study
• Body Mass index (BMI) greater than 40
• Patients with active tumors in the spinal region
• Patients who have been diagnosed to diabetes mellitus
• Patients who have a sensitivity or allergy to the implant materials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Device: HYDRAFIL; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success	Successful implantation of the ReGelTec HYDRAFIL System implant in a lumbar disc nucleus	post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Back pain as measured by NRS	Decrease in Numeric Rating Scale (NRS) Score - Back Pain	3, 6, 12 and 24 months
Function as measured by ODI	Maintenance of, or further improvement in the Oswestry Disability Index (ODI) Score	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	Freedom from Device or Operative Related Serious Adverse Events (SAEs)	3, 6, 12 and 24 months

Collaborators and Investigators

• Sponsor: ReGelTec, Inc.
• Investigators: Principal Investigator: Olivier Clerk-Lamalice, MD, MSc, FRCPC, FIPP, Beam Interventional & Diagnostic Imaging

Publications and helpful links

Helpful Links

• Sponsor Website

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: DDD; Degenerative Disc Disease; Back Pain; Lumbar Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Back Pain; Low Back Pain; Intervertebral Disc Degeneration
• Other Study ID Numbers: RGOUS -1000CAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No