Study of the ReGelTec HYDRAFIL System

January 30, 2026 updated by: ReGelTec, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Robert Townsend, Sr. Director Clinical Affairs
  • Phone Number: 443-451-3915
  • Email: rtownsend@regeltec.com

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Success
Time Frame: post-treatment
Successful implantation of the ReGelTec HYDRAFIL System implant in a lumbar disc nucleus
post-treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Back pain as measured by NRS
Time Frame: 3, 6, 12 and 24 months
Decrease in Numeric Rating Scale (NRS) Score - Back Pain
3, 6, 12 and 24 months
Function as measured by ODI
Time Frame: 3, 6, 12 and 24 months
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
Time Frame: 3, 6, 12 and 24 months
Freedom from Device or Operative Related Serious Adverse Events (SAEs)
3, 6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ReGelTec, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Olivier Clerk-Lamalice, MD, MSc, FRCPC, FIPP, Beam Interventional & Diagnostic Imaging

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings