Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2022-01-04
2025-10-30
Brief Summary
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Detailed Description
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The primary objective of this study is to evaluate the safety and efficacy the HYDRAFIL System.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HYDRAFIL Implant
Polymer Implant of HYDRAFIL into a one or two lumbar intervertebral discs
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
22 Years
80 Years
ALL
No
Sponsors
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ReGelTec, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Olivier Clerk-Lamalice, MD, MSc, FRCPC, FIPP
Role: PRINCIPAL_INVESTIGATOR
Beam Interventional & Diagnostic Imaging
Locations
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Beam Interventional & Diagnostic Imaging
Calgary, Alberta, Canada
Countries
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Related Links
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Sponsor Website
Other Identifiers
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RGOUS -1000CAN
Identifier Type: -
Identifier Source: org_study_id
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