xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06011551</url>
    </required_header>
    <id_info>
      <org_study_id>RGT-2000PS</org_study_id>
      <nct_id>NCT06011551</nct_id>
    </id_info>
    <brief_title>HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs</brief_title>
    <acronym>HYDRAFIL-D</acronym>
    <official_title>HYDRAFIL-D: HYDRogel Augmentation For Intervertebral Lumbar Discs</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ReGelTec, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ReGelTec, Inc.</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the&#xD;
        safety and effectiveness of the ReGelTec HYDRAFIL™ System.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This pivotal study is designed to evaluate the safety and effectiveness of the ReGelTec&#xD;
        HYDRAFIL System in subjects with axial chronic low back pain (CLBP) due to degenerative disc&#xD;
        disease (DDD) who continue to have severe back pain and dysfunction after at least six (6)&#xD;
        months of conservative care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">July 2027</completion_date>
    <primary_completion_date type="Anticipated">July 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Prospective, dual arm, randomized, controlled pivotal study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Single-blind (participants will be blinded to treatment assignment)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Composite Endpoint of Clinical Success</measure>
      <time_frame>12-month</time_frame>
      <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.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">225</enrollment>
    <condition>Degenerative Disc Disease (DDD)</condition>
    <arm_group>
      <arm_group_label>Treatment Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group A: continued non-surgical conservative medical management plus a percutaneous hydrogel spinal implant delivered via the HYDRAFIL System (the HYDRAFIL implant) (the &quot;Treatment Arm&quot;)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Arm</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <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 &quot;Control Arm&quot;)</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>The ReGelTec HYDRAFIL™ System</intervention_name>
      <description>The ReGelTec HYDRAFIL System is designed to deliver an injectable hydrogel implant (the HYDRAFIL implant) for the treatment of a degenerative lumbar disc.</description>
      <arm_group_label>Treatment Arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Conservative Care Management</intervention_name>
      <description>Conservative care management (including physical therapy and/or pain medication)</description>
      <arm_group_label>Control Arm</arm_group_label>
      <arm_group_label>Treatment Arm</arm_group_label>
      <other_name>Non-surgical conservative medical management</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female subjects aged 22 to 85 years, inclusive&#xD;
  &#xD;
            -  Present with LBP greater than leg pain and symptoms of DDD of the lumbar region (L1-&#xD;
               S1) of at least six (6) months duration&#xD;
  &#xD;
            -  The presence of one (1) or two (2) symptomatic disc(s) (i.e., only 1-level or 2-levels&#xD;
               may be treated during the study) as determined by discography&#xD;
  &#xD;
            -  Symptomatic disc(s) exhibiting Grade 4 to 8 degeneration on the modified Pfirrmann&#xD;
               scale as determined by MRI&#xD;
  &#xD;
            -  Failure to have their symptoms resolve or reduce following six (6) months conservative&#xD;
               care (as defined in the body of the protocol)&#xD;
  &#xD;
            -  Psychosocially, mentally and physically able and willing to fully comply with this&#xD;
               protocol including adhering to follow-up schedule and requirements and filling out&#xD;
               forms&#xD;
  &#xD;
            -  English fluency&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of or active systemic or local infection&#xD;
  &#xD;
            -  Any skin disease or inadequate tissue coverage at the site of the proposed injection&#xD;
  &#xD;
            -  Annular tear or defect that shows free contrast extravasation into the epidural space&#xD;
               during or after discography&#xD;
  &#xD;
            -  Presence of more than two (2) symptomatic discs presenting with pain confirmed during&#xD;
               discography&#xD;
  &#xD;
            -  Presence of extruded or sequestered disc herniation (i.e., disc extrusions or&#xD;
               sequestrations) at the symptomatic level(s) or on adjacent levels&#xD;
  &#xD;
            -  Presence of wide annular fissures confluent with large disc protrusions at the&#xD;
               symptomatic level(s)&#xD;
  &#xD;
            -  Epidural steroid injection, intradiscal injection, trigger point injection, facet or&#xD;
               medial branch block within 60 days of enrollment&#xD;
  &#xD;
            -  Opioid medication usage &gt;60 MME (morphine milligram equivalent)/day or change/increase&#xD;
               in opioid prescription within 60 days of enrollment&#xD;
  &#xD;
            -  Subjects with Modic type 3 changes&#xD;
  &#xD;
            -  Subjects presenting with radicular pain greater than back pain or by history within&#xD;
               the past six (6) months. Radicular pain is defined as nerve pain following a&#xD;
               dermatomal distribution and that correlates with nerve compression on imaging. Somatic&#xD;
               referred pain is allowed&#xD;
  &#xD;
            -  Neurogenic claudication due to spinal stenosis&#xD;
  &#xD;
            -  Subjects with any prior back surgery or invasive spinal procedure of the lumbar spine&#xD;
  &#xD;
            -  History of vertebral fractures in the lumbar spine&#xD;
  &#xD;
            -  Evidence of severe compression of cauda equina&#xD;
  &#xD;
            -  Spinal segmental instability (spondylolysis or spondylolisthesis: Grade &gt;1), severe&#xD;
               spinal canal stenosis, isthmus pathology, scoliosis [Cobb angle &gt;20 at the index&#xD;
               level(s)]&#xD;
  &#xD;
            -  Subjects with arachnoiditis&#xD;
  &#xD;
            -  Subjects who are prisoners of wards or courts&#xD;
  &#xD;
            -  Subjects involved in active litigation including worker's compensation cases&#xD;
  &#xD;
            -  Subjects on chronic anticoagulation due to a bleeding disorder and is unable to safely&#xD;
               stop anticoagulants or has taken anticoagulants within three (3) days prior to&#xD;
               procedure&#xD;
  &#xD;
            -  Subjects with LBP of non-spinal or unknown etiology&#xD;
  &#xD;
            -  Subjects who have a history (in the last 5 years) of substance abuse or chemical&#xD;
               dependency (pharmaceuticals, illicit drugs, alcohol) or are current abusers (using&#xD;
               definition criteria from the Diagnostic and Statistical Manual of Mental Disorders&#xD;
               (DSM-V))&#xD;
  &#xD;
            -  Subjects who have major psychiatric disorders, such as major depression, bipolar&#xD;
               disorder and schizophrenia, as defined by the DSM-V&#xD;
  &#xD;
            -  If female, subjects who are pregnant or are trying to become pregnant during the&#xD;
               course of the trial (due to risks of additional radiation exposures)&#xD;
  &#xD;
            -  Failure to understand informed consent or inability or unwillingness to adhere to the&#xD;
               study follow-up visit schedule or other protocol requirements&#xD;
  &#xD;
            -  Have participated in any other clinical trial within the last three (3) months, and&#xD;
               active or planned participation in any other clinical study during the course of this&#xD;
               trial. Note: subjects must agree they will not participate in any other&#xD;
               investigational clinical trial during this study&#xD;
  &#xD;
            -  Body Mass Index (BMI) &gt;35 kg/m2&#xD;
  &#xD;
            -  Current smoker or nicotine and/ or tobacco user&#xD;
  &#xD;
            -  Known allergy or hypersensitivity to device material&#xD;
  &#xD;
            -  Endocrine or metabolic disorder known to affect osteogenesis&#xD;
  &#xD;
            -  Insulin-dependent diabetes mellitus&#xD;
  &#xD;
            -  Inability to undergo X-ray, MRI (magnetic resonance imaging), or CT (computed&#xD;
               tomography) scans or other radiographic assessments, including discography&#xD;
  &#xD;
            -  Any comorbid medical condition which, in the best judgement of the Investigator, would&#xD;
               make the subject unsuitable for inclusion in the study or interferes with the proper&#xD;
               assessment of safety or effectiveness (e.g., systemic disease)&#xD;
  &#xD;
            -  Subjects with any active malignancy or who have been previously diagnosed with a&#xD;
               malignancy and have evidence of residual disease&#xD;
  &#xD;
            -  Any degenerative or neurological condition that would interfere with evaluation of&#xD;
               outcomes or that may generate an unacceptable risk of failure or postoperative&#xD;
               complications&#xD;
  &#xD;
            -  Chronic or acute renal and/ or hepatic impairment&#xD;
  &#xD;
            -  Severe osteoporosis. The SCORES/MORES will be utilized to screen if a DEXA scan is&#xD;
               indicated. If SCORES/MORES value ≥ 6; then a DEXA scan is required. Severe&#xD;
               osteoporosis is defined as DEXA T-score &lt; 2.5 (spine or hip) or QCT T-score &lt;&#xD;
               80mg/cubic cm&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Douglas Beall, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Clinical Investigations LLC</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Kasra Amirdelfan, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>IPM Medical Group</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Robert Townsend</last_name>
      <phone>443-451-3915</phone>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Elisa B Storyk, MPH, CCRP</last_name>
      <phone>443-451-3915</phone>
    </overall_contact_backup>
    <link>
      <url>https://regeltec.com/</url>
      <description>Sponsor Company Website</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Intervertebral Disc</keyword>
    <keyword>Nucleus Pulposus</keyword>
    <keyword>Disc Augmentation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intervertebral Disc Degeneration</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06011551
  org study id: RGT-2000PS
  nct id: NCT06011551
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  A multi-center, prospective, dual arm, randomized, controlled pivotal study to evaluate the
        safety and effectiveness of the ReGelTec HYDRAFIL™ System.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective, dual arm, randomized, controlled pivotal study
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Single-blind (participants will be blinded to treatment assignment)
  measure: Composite Endpoint of Clinical Success
  time frame: 12-month
  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.
  arm group label: Treatment Arm
  arm group type: Experimental
  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 group label: Control Arm
  arm group type: Sham Comparator
  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: The ReGelTec HYDRAFIL™ System
  description: The ReGelTec HYDRAFIL System is designed to deliver an injectable hydrogel implant (the HYDRAFIL implant) for the treatment of a degenerative lumbar disc.
  arm group label: Treatment Arm
  intervention type: Other
  intervention name: Conservative Care Management
  description: Conservative care management (including physical therapy and/or pain medication)
  arm group label: Control Arm
  arm group label: Treatment Arm
  other name: Non-surgical conservative medical management
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: 85 Years
  healthy volunteers: No
  last name: Douglas Beall, MD
  role: Principal Investigator
  affiliation: Clinical Investigations LLC
  last name: Kasra Amirdelfan, MD
  role: Principal Investigator
  affiliation: IPM Medical Group
  last name: Robert Townsend
  phone: 443-451-3915
  last name: Elisa B Storyk, MPH, CCRP
  phone: 443-451-3915
  url: https://regeltec.com/
  description: Sponsor Company Website
  responsible party type: Sponsor
  mesh term: Intervertebral Disc Degeneration
  sharing ipd: No