Study of the ReGelTec HYDRAFIL System
Primary Purpose
Degenerative Disc Disease
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HYDRAFIL
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease focused on measuring DDD, Degenerative Disc Disease, Back Pain, Lumbar Pain
Eligibility Criteria
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 12 weeks 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 imaging and provocative discography and/or anaesthetic discography at L1-L2, L2-L3, L3-L4, L4-L5, and L5-S1.
- Patients presenting with a pain level of ≥ 4 out of 10 on the NRS scale and an Oswestry Disability Index (ODI) score of ≥ 30.
- 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 >10 at the incident level] and other deformity conditions that may compromise the study
- Subjects with arachnoiditis
- Subjects who are prisoners of wards or 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
Sites / Locations
- Beam Interventional & Diagnostic ImagingRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HYDRAFIL Implant
Arm Description
Polymer Implant of HYDRAFIL into a one or two lumbar intervertebral discs
Outcomes
Primary Outcome Measures
Success
Successful implantation of the ReGelTec HYDRAFIL System implant in a lumbar disc nucleus
Secondary Outcome Measures
Back pain as measured by NRS
Decrease in Numeric Rating Scale (NRS) Score - Back Pain
Function as measured by ODI
Maintenance of, or further improvement in the Oswestry Disability Index (ODI) Score
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04984629
Brief Title
Study of the ReGelTec HYDRAFIL System
Official Title
Prospective, Single Arm, Non-randomized, Traditional Feasibility Study to Evaluate the Safety and Performance of the ReGelTec HYDRAFIL System
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
January 4, 2024 (Anticipated)
Study Completion Date
January 4, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ReGelTec, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
Keywords
DDD, Degenerative Disc Disease, Back Pain, Lumbar Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects will receive the HYDRAFIL implant
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HYDRAFIL Implant
Arm Type
Experimental
Arm Description
Polymer Implant of HYDRAFIL into a one or two lumbar intervertebral discs
Intervention Type
Device
Intervention Name(s)
HYDRAFIL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Success
Description
Successful implantation of the ReGelTec HYDRAFIL System implant in a lumbar disc nucleus
Time Frame
post-treatment
Secondary Outcome Measure Information:
Title
Back pain as measured by NRS
Description
Decrease in Numeric Rating Scale (NRS) Score - Back Pain
Time Frame
3, 6, 12 and 24 months
Title
Function as measured by ODI
Description
Maintenance of, or further improvement in the Oswestry Disability Index (ODI) Score
Time Frame
3, 6, 12 and 24 months
Title
Safety of the ReGelTec Implant by demonstrating durability over the long term and no unanticipated safety concerns that arise
Description
Freedom from Device or Operative Related Serious Adverse Events (SAEs)
Time Frame
3, 6, 12 and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Townsend, Sr. Director Clinical Affairs
Phone
443-451-3915
Email
rtownsend@regeltec.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Clerk-Lamalice, MD, MSc, FRCPC, FIPP
Organizational Affiliation
Beam Interventional & Diagnostic Imaging
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beam Interventional & Diagnostic Imaging
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3K6G4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Clerk
First Name & Middle Initial & Last Name & Degree
Olivier Clerk-Lamalice, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.regeltec.com
Description
Sponsor Website
Learn more about this trial
Study of the ReGelTec HYDRAFIL System
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