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HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs (HYDRAFIL-D)

Primary Purpose

Degenerative Disc Disease (DDD)

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The ReGelTec HYDRAFIL™ System
Conservative Care Management
Sponsored by
ReGelTec, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease (DDD) focused on measuring Intervertebral Disc, Nucleus Pulposus, Disc Augmentation

Eligibility Criteria

22 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female subjects aged 22 to 85 years, inclusive Present with LBP greater than leg pain and symptoms of DDD of the lumbar region (L1- S1) of at least six (6) months duration The presence of one (1) or two (2) symptomatic disc(s) (i.e., only 1-level or 2-levels may be treated during the study) as determined by discography Symptomatic disc(s) exhibiting Grade 4 to 8 degeneration on the modified Pfirrmann scale as determined by MRI Failure to have their symptoms resolve or reduce following six (6) months conservative care (as defined in the body of the protocol) Psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms English fluency Signed informed consent Exclusion Criteria: History of or active systemic or local infection Any skin disease or inadequate tissue coverage at the site of the proposed injection Annular tear or defect that shows free contrast extravasation into the epidural space during or after discography Presence of more than two (2) symptomatic discs presenting with pain confirmed during discography Presence of extruded or sequestered disc herniation (i.e., disc extrusions or sequestrations) at the symptomatic level(s) or on adjacent levels Presence of wide annular fissures confluent with large disc protrusions at the symptomatic level(s) Epidural steroid injection, intradiscal injection, trigger point injection, facet or medial branch block within 60 days of enrollment Opioid medication usage >60 MME (morphine milligram equivalent)/day or change/increase in opioid prescription within 60 days of enrollment Subjects with Modic type 3 changes Subjects presenting with radicular pain greater than back pain or by history within the past six (6) months. Radicular pain is defined as nerve pain following a dermatomal distribution and that correlates with nerve compression on imaging. Somatic referred pain is allowed Neurogenic claudication due to spinal stenosis Subjects with any prior back surgery or invasive spinal procedure of the lumbar spine History of vertebral fractures in the lumbar spine Evidence of severe compression of cauda equina Spinal segmental instability (spondylolysis or spondylolisthesis: Grade >1), severe spinal canal stenosis, isthmus pathology, scoliosis [Cobb angle >20 at the index level(s)] Subjects with arachnoiditis Subjects who are prisoners of wards or courts Subjects involved in active litigation including worker's compensation cases Subjects on chronic anticoagulation due to a bleeding disorder and is unable to safely stop anticoagulants or has taken anticoagulants within three (3) days prior to procedure Subjects with LBP of non-spinal or unknown etiology Subjects who have a history (in the last 5 years) of substance abuse or chemical dependency (pharmaceuticals, illicit drugs, alcohol) or are current abusers (using definition criteria from the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)) Subjects who have major psychiatric disorders, such as major depression, bipolar disorder and schizophrenia, as defined by the DSM-V If female, subjects 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 inability or unwillingness to adhere to the study follow-up visit schedule or other protocol requirements Have participated in any other clinical trial within the last three (3) months, and active or planned participation in any other clinical study during the course of this trial. Note: subjects must agree they will not participate in any other investigational clinical trial during this study Body Mass Index (BMI) >35 kg/m2 Current smoker or nicotine and/ or tobacco user Known allergy or hypersensitivity to device material Endocrine or metabolic disorder known to affect osteogenesis Insulin-dependent diabetes mellitus Inability to undergo X-ray, MRI (magnetic resonance imaging), or CT (computed tomography) scans or other radiographic assessments, including discography Any comorbid medical condition which, in the best judgement of the Investigator, would make the subject unsuitable for inclusion in the study or interferes with the proper assessment of safety or effectiveness (e.g., systemic disease) Subjects with any active malignancy or who have been previously diagnosed with a malignancy and have evidence of residual disease Any degenerative or neurological condition that would interfere with evaluation of outcomes or that may generate an unacceptable risk of failure or postoperative complications Chronic or acute renal and/ or hepatic impairment Severe osteoporosis. The SCORES/MORES will be utilized to screen if a DEXA scan is indicated. If SCORES/MORES value ≥ 6; then a DEXA scan is required. Severe osteoporosis is defined as DEXA T-score < 2.5 (spine or hip) or QCT T-score < 80mg/cubic cm

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Treatment Arm

    Control Arm

    Arm Description

    Group A: continued non-surgical conservative medical management plus a percutaneous hydrogel spinal implant delivered via the HYDRAFIL System (the HYDRAFIL implant) (the "Treatment Arm")

    Group B: continued non-surgical conservative medical management plus advancement of the HYDRAFIL System delivery needle to the outside of the target disc(s) without contacting the outer edge of the annular fibers (the "Control Arm")

    Outcomes

    Primary Outcome Measures

    Composite Endpoint of Clinical Success
    The primary endpoint is a single composite endpoint reflecting five study outcomes (function, SAEs, SSIs, intercurrent events, and radiographic findings). The individual subject's outcome will be considered a success if all of the criteria are met at 12 months.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 21, 2023
    Last Updated
    September 1, 2023
    Sponsor
    ReGelTec, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06011551
    Brief Title
    HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs
    Acronym
    HYDRAFIL-D
    Official Title
    HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    July 2026 (Anticipated)
    Study Completion Date
    July 2027 (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
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL™ System.
    Detailed Description
    This pivotal study is designed to evaluate the safety and effectiveness of the ReGelTec HYDRAFIL System in subjects with axial chronic low back pain (CLBP) due to degenerative disc disease (DDD) who continue to have severe back pain and dysfunction after at least six (6) months of conservative care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Degenerative Disc Disease (DDD)
    Keywords
    Intervertebral Disc, Nucleus Pulposus, Disc Augmentation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective, dual arm, randomized, controlled pivotal study
    Masking
    Participant
    Masking Description
    Single-blind (participants will be blinded to treatment assignment)
    Allocation
    Randomized
    Enrollment
    225 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Arm
    Arm Type
    Experimental
    Arm Description
    Group A: continued non-surgical conservative medical management plus a percutaneous hydrogel spinal implant delivered via the HYDRAFIL System (the HYDRAFIL implant) (the "Treatment Arm")
    Arm Title
    Control Arm
    Arm Type
    Sham Comparator
    Arm Description
    Group B: continued non-surgical conservative medical management plus advancement of the HYDRAFIL System delivery needle to the outside of the target disc(s) without contacting the outer edge of the annular fibers (the "Control Arm")
    Intervention Type
    Device
    Intervention Name(s)
    The ReGelTec HYDRAFIL™ System
    Intervention Description
    The ReGelTec HYDRAFIL System is designed to deliver an injectable hydrogel implant (the HYDRAFIL implant) for the treatment of a degenerative lumbar disc.
    Intervention Type
    Other
    Intervention Name(s)
    Conservative Care Management
    Other Intervention Name(s)
    Non-surgical conservative medical management
    Intervention Description
    Conservative care management (including physical therapy and/or pain medication)
    Primary Outcome Measure Information:
    Title
    Composite Endpoint of Clinical Success
    Description
    The primary endpoint is a single composite endpoint reflecting five study outcomes (function, SAEs, SSIs, intercurrent events, and radiographic findings). The individual subject's outcome will be considered a success if all of the criteria are met at 12 months.
    Time Frame
    12-month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female subjects aged 22 to 85 years, inclusive Present with LBP greater than leg pain and symptoms of DDD of the lumbar region (L1- S1) of at least six (6) months duration The presence of one (1) or two (2) symptomatic disc(s) (i.e., only 1-level or 2-levels may be treated during the study) as determined by discography Symptomatic disc(s) exhibiting Grade 4 to 8 degeneration on the modified Pfirrmann scale as determined by MRI Failure to have their symptoms resolve or reduce following six (6) months conservative care (as defined in the body of the protocol) Psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms English fluency Signed informed consent Exclusion Criteria: History of or active systemic or local infection Any skin disease or inadequate tissue coverage at the site of the proposed injection Annular tear or defect that shows free contrast extravasation into the epidural space during or after discography Presence of more than two (2) symptomatic discs presenting with pain confirmed during discography Presence of extruded or sequestered disc herniation (i.e., disc extrusions or sequestrations) at the symptomatic level(s) or on adjacent levels Presence of wide annular fissures confluent with large disc protrusions at the symptomatic level(s) Epidural steroid injection, intradiscal injection, trigger point injection, facet or medial branch block within 60 days of enrollment Opioid medication usage >60 MME (morphine milligram equivalent)/day or change/increase in opioid prescription within 60 days of enrollment Subjects with Modic type 3 changes Subjects presenting with radicular pain greater than back pain or by history within the past six (6) months. Radicular pain is defined as nerve pain following a dermatomal distribution and that correlates with nerve compression on imaging. Somatic referred pain is allowed Neurogenic claudication due to spinal stenosis Subjects with any prior back surgery or invasive spinal procedure of the lumbar spine History of vertebral fractures in the lumbar spine Evidence of severe compression of cauda equina Spinal segmental instability (spondylolysis or spondylolisthesis: Grade >1), severe spinal canal stenosis, isthmus pathology, scoliosis [Cobb angle >20 at the index level(s)] Subjects with arachnoiditis Subjects who are prisoners of wards or courts Subjects involved in active litigation including worker's compensation cases Subjects on chronic anticoagulation due to a bleeding disorder and is unable to safely stop anticoagulants or has taken anticoagulants within three (3) days prior to procedure Subjects with LBP of non-spinal or unknown etiology Subjects who have a history (in the last 5 years) of substance abuse or chemical dependency (pharmaceuticals, illicit drugs, alcohol) or are current abusers (using definition criteria from the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)) Subjects who have major psychiatric disorders, such as major depression, bipolar disorder and schizophrenia, as defined by the DSM-V If female, subjects 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 inability or unwillingness to adhere to the study follow-up visit schedule or other protocol requirements Have participated in any other clinical trial within the last three (3) months, and active or planned participation in any other clinical study during the course of this trial. Note: subjects must agree they will not participate in any other investigational clinical trial during this study Body Mass Index (BMI) >35 kg/m2 Current smoker or nicotine and/ or tobacco user Known allergy or hypersensitivity to device material Endocrine or metabolic disorder known to affect osteogenesis Insulin-dependent diabetes mellitus Inability to undergo X-ray, MRI (magnetic resonance imaging), or CT (computed tomography) scans or other radiographic assessments, including discography Any comorbid medical condition which, in the best judgement of the Investigator, would make the subject unsuitable for inclusion in the study or interferes with the proper assessment of safety or effectiveness (e.g., systemic disease) Subjects with any active malignancy or who have been previously diagnosed with a malignancy and have evidence of residual disease Any degenerative or neurological condition that would interfere with evaluation of outcomes or that may generate an unacceptable risk of failure or postoperative complications Chronic or acute renal and/ or hepatic impairment Severe osteoporosis. The SCORES/MORES will be utilized to screen if a DEXA scan is indicated. If SCORES/MORES value ≥ 6; then a DEXA scan is required. Severe osteoporosis is defined as DEXA T-score < 2.5 (spine or hip) or QCT T-score < 80mg/cubic cm
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Robert Townsend
    Phone
    443-451-3915
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elisa B Storyk, MPH, CCRP
    Phone
    443-451-3915
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Douglas Beall, MD
    Organizational Affiliation
    Clinical Investigations LLC
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Kasra Amirdelfan, MD
    Organizational Affiliation
    IPM Medical Group
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Links:
    URL
    https://regeltec.com/
    Description
    Sponsor Company Website

    Learn more about this trial

    HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs

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