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Study of the ReGelTec HYDRAFIL System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04984629
Recruitment Status : Recruiting
First Posted : July 30, 2021
Last Update Posted : April 27, 2023
Sponsor:
Information provided by (Responsible Party):
ReGelTec, Inc.

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

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Device: HYDRAFIL Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects will receive the HYDRAFIL implant
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Single Arm, Non-randomized, Traditional Feasibility Study to Evaluate the Safety and Performance of the ReGelTec HYDRAFIL System
Actual Study Start Date : January 4, 2022
Estimated Primary Completion Date : January 4, 2024
Estimated Study Completion Date : January 4, 2026

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Success [ Time Frame: post-treatment ]
    Successful implantation of the ReGelTec HYDRAFIL System implant in a lumbar disc nucleus


Secondary Outcome Measures :
  1. Back pain as measured by NRS [ Time Frame: 3, 6, 12 and 24 months ]
    Decrease in Numeric Rating Scale (NRS) Score - Back Pain

  2. 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. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04984629


Contacts
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Contact: Robert Townsend, Sr. Director Clinical Affairs 443-451-3915 rtownsend@regeltec.com

Locations
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Canada, Alberta
Beam Interventional & Diagnostic Imaging Recruiting
Calgary, Alberta, Canada, T3K6G4
Contact: Olivier Clerk         
Principal Investigator: Olivier Clerk-Lamalice, MD         
Sponsors and Collaborators
ReGelTec, Inc.
Investigators
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Principal Investigator: Olivier Clerk-Lamalice, MD, MSc, FRCPC, FIPP Beam Interventional & Diagnostic Imaging
Additional Information:
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Responsible Party: ReGelTec, Inc.
ClinicalTrials.gov Identifier: NCT04984629    
Other Study ID Numbers: RGOUS -1000CAN
First Posted: July 30, 2021    Key Record Dates
Last Update Posted: April 27, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ReGelTec, Inc.:
DDD
Degenerative Disc Disease
Back Pain
Lumbar Pain
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases