<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/NCT03252691</url>
  </required_header>
  <id_info>
    <org_study_id>USCONTROL-USLSI-001</org_study_id>
    <nct_id>NCT03252691</nct_id>
  </id_info>
  <brief_title>Incidence of Large Annular Defects in Primary Lumbar Discectomy Patients</brief_title>
  <acronym>USLSI</acronym>
  <official_title>Study to Determine Incidence of Large Annular Defects And Measurement of Volume of Nucleus Removed in Primary Discectomy Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intrinsic Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intrinsic Therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lumbar discectomy study, collection and evaluation of incidence of large annular defects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed as a single-site prospective data collection. Measurements will be&#xD;
      collected during 150 consecutive standard of care primary lumbar discectomy procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Site closure and no patient enrolled&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Actual">May 18, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of large defects noted on primary lumbar discectomy procedure.</measure>
    <time_frame>Intra-operatively</time_frame>
    <description>Annular defect size will be measured intra-operatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantify the amount of nuclear disc material removed during primary lumbar discectomy procedure.</measure>
    <time_frame>Intra-operatively</time_frame>
    <description>Amount of nucleus removed will be measured intra-operatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verify access to annular defect with approved manual surgical instruments.</measure>
    <time_frame>Intra-operatively</time_frame>
    <description>Access to the annular defect will be evaluated intra-operatively.</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Lumbar Disc Herniation</condition>
  <condition>Anular Tear of Lumbar Disc</condition>
  <condition>Nucleus Pulp Hernia;Lumbosac</condition>
  <eligibility>
    <study_pop>
      <textblock>
        One hundred and fifty (150) subjects will participate in the study. Participants will be&#xD;
        between 18 and 75 years of age. All subjects will have been diagnosed with primary lumbar&#xD;
        disc herniation requiring surgical discectomy as per the opinion of the treating surgeon.&#xD;
        All subjects who meet the inclusion criteria, do not meet any of the exclusion criteria,&#xD;
        and who elect to participate and sign the informed consent will be included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Must be 18-75 years of age, and skeletally mature&#xD;
&#xD;
          2. Must have clinical and radiological evidence of primary lumbar disc herniation at one&#xD;
             level of the lumbar spine between L3-S1.&#xD;
&#xD;
          3. Must be psychosocially, mentally and physically able to comply with protocol,&#xD;
             post-operative management and follow-up care.&#xD;
&#xD;
          4. Subject must understand and sign the written Informed Consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior surgery at the index lumbar vertebral level.&#xD;
&#xD;
          2. Subject requires spinal surgery other than a discectomy (with or without laminotomy)&#xD;
             to treat leg/back pain&#xD;
&#xD;
          3. Morbid obesity (BMI ≥ 40 kg/m2)&#xD;
&#xD;
          4. Investigational drug or device use within 30 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Reginald Davis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Laser Spine Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Laser Spine Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>May 18, 2021</last_update_submitted>
  <last_update_submitted_qc>May 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intervertebral Disc Displacement</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03252691
org study id: USCONTROL-USLSI-001
nct id: NCT03252691
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Lumbar discectomy study, collection and evaluation of incidence of large annular defects.
This study is designed as a single-site prospective data collection. Measurements will be
      collected during 150 consecutive standard of care primary lumbar discectomy procedures.
observational model: Cohort
time perspective: Prospective
measure: Incidence of large defects noted on primary lumbar discectomy procedure.
time frame: Intra-operatively
description: Annular defect size will be measured intra-operatively.
measure: Quantify the amount of nuclear disc material removed during primary lumbar discectomy procedure.
time frame: Intra-operatively
description: Amount of nucleus removed will be measured intra-operatively.
measure: Verify access to annular defect with approved manual surgical instruments.
time frame: Intra-operatively
description: Access to the annular defect will be evaluated intra-operatively.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Reginald Davis, MD
role: Principal Investigator
affiliation: Laser Spine Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Intervertebral Disc Displacement