Degenerative Disc DiseaseNCT04984629
Study of the ReGelTec HYDRAFIL System
A study testing HYDRAFIL in people with Degenerative Disc Disease, run by ReGelTec, Inc. at 1 site in Canada.
Trial summary
A study designed to treat patients with back pain associated with degenerative lumbar disc disease. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- HYDRAFIL
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jan 2022to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Degenerative Disc Disease
- Being tested
- HYDRAFIL
- Keywords
- DDD, Degenerative Disc Disease, Back Pain, Lumbar Pain
- Medical subject headings
- Intervertebral Disc Degeneration, Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYDRAFILDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HYDRAFIL Implant | Experimental | Polymer Implant of HYDRAFIL into a one or two lumbar intervertebral discs Receives: Device: HYDRAFIL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success
Successful implantation of the ReGelTec HYDRAFIL System implant in a lumbar disc nucleus
Measured: post-treatment
Secondary outcomes (3)
Back pain as measured by NRS
Decrease in Numeric Rating Scale (NRS) Score - Back Pain
Measured: 3, 6, 12 and 24 months
Function as measured by ODI
Maintenance of, or further improvement in the Oswestry Disability Index (ODI) Score
Measured: 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)
Measured: 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start4 Jan 2022
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will receive the HYDRAFIL implant
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReGelTec, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olivier Clerk-Lamalice, MD, MSc, FRCPC, FIPP, Principal investigator, Beam Interventional & Diagnostic Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984629
- Sponsor's protocol ID
- RGOUS -1000CAN
- Status last verified
- Jan 2026
- First submitted
- 14 Jul 2021
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Arm, Non-randomized, Traditional Feasibility Study to Evaluate the Safety and Performance of the ReGelTec HYDRAFIL System
- ClinicalTrials.gov ID
- NCT04984629
- Acronym / sponsor ID
- RGOUS -1000CAN
- Conditions
- Degenerative Disc Disease
- Keywords
- DDD, Degenerative Disc Disease, Back Pain, Lumbar Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- ReGelTec, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study designed to treat patients with back pain associated with degenerative lumbar disc disease.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will receive the HYDRAFIL implant
| Arm | Type | Receives |
|---|---|---|
| HYDRAFIL Implant | Experimental | Device: HYDRAFILPolymer Implant of HYDRAFIL into a one or two lumbar intervertebral discs |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HYDRAFILThe 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. | Device | HYDRAFIL Implant |
Primary outcome
Success
Time frame: post-treatment
Successful implantation of the ReGelTec HYDRAFIL System implant in a lumbar disc nucleus
3 secondary outcomes
Back pain as measured by NRS
Time frame: 3, 6, 12 and 24 months
Function as measured by ODI
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Sponsor WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Clerk-Lamalice, MD, MSc, FRCPC, FIPP principal investigator
Beam Interventional & Diagnostic Imaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HYDRAFIL in people with Degenerative Disc Disease, run by ReGelTec, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success (time frame: post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.