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/NCT05969392</url>
    </required_header>
    <id_info>
      <org_study_id>CLI01068</org_study_id>
      <nct_id>NCT05969392</nct_id>
    </id_info>
    <brief_title>Evaluation of Efficacy and Safety of Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain</brief_title>
    <acronym>DISCERV</acronym>
    <official_title>Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain : a Interventional, Prospective, Multi-center, Open-label Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gelscom SAS</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gelscom SAS</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>
        The purpose of this study is to assesse safety and efficacy of the Intradiscal Gelified&#xD;
        Ethanol for treatment in refractory cervical discogenic pain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After being informed about the study and potential tisks, all patients giving written&#xD;
        informed consent will undergo a inclusion visit (CT scan and X ray at least) for study entry.&#xD;
        At Day 0, operation with Intradiscal Gelified Ethanol will be performed by the investigator.&#xD;
        Follow visit will be performed at 3 months and 12 months&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">May 2025</completion_date>
    <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
    <phase>Phase 2/Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>the mean change in pain intensity assessed by a verbal local rating scale (pain intensity numerical scale) between the pre-treatment measurement (inclusion visi) and the post-treatment measurement (Visit 2 at the 3 months)</measure>
      <time_frame>3 months</time_frame>
      <description>In a 11-point numeric scale, 0 represents &quot;NO PAIN&quot; and 10 represents &quot;EXTREME PAIN&quot; (e.g., &quot;pain as bad as you can imagine&quot; and &quot;worst pain imaginable&quot;).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in pain cervical intensity using the verbal local rating scale [</measure>
      <time_frame>12 months</time_frame>
      <description>Scores range from 0-10. In a 11-point numeric scale, 0 represents &quot;NO PAIN&quot; and 10 represents &quot;EXTREME PAIN&quot; (e.g., &quot;pain as bad as you can imagine&quot; and &quot;worst pain imaginable&quot;).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of consumption of painkillers</measure>
      <time_frame>12 months</time_frame>
      <description>Number, frequency and dosage of pain relief treatments will be combine todescribe the difference in painkiller consumption before and after the operation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of complication and adverse event rates</measure>
      <time_frame>12 months</time_frame>
      <description>Incidence of adverse event during 12 months after the treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ability to manage everyday-life activity (Neck Disability Index (NDI) scale) [Time Frame : inclusion, 3 and 12 months after treatment].</measure>
      <time_frame>12 months</time_frame>
      <description>The Neck Disability Index (NDI) is used to measure pain-related disability associated with activities of daily living in people with neck pain (index between 0 and 50). The original report provided scoring intervals for interpretation, as follows: 0 - 4 = no disability, 5 - 14 = mild, 15 - 24 = moderate, 25 - 34 = severe, above 34 = complete. The NDI contains 10 items-7 related to activities of daily living, 2 related to pain, and 1 related to concentration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective evaluation MacNab</measure>
      <time_frame>12 months after treatment</time_frame>
      <description>The MacNab's scale is layered into 4 levels (excellent, good, fair and poor) according to the patient's well-being after surgery or procedure.The scores were divided into the following four grades: 75-100% (excellent), 50-74% (good), 25-49% (fair) and 0-24% (poor). &quot;Excellent&quot; is defined as &quot;No pain; no restriction of activity&quot;. &quot;Good&quot; is defined as &quot;Occasional pain of sufficient severity to interfere with the patient's ability to do his normal work or his capacity to enjoy himself in leisure hours&quot;.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Pain, Cervical</condition>
    <condition>Discogenic Pain</condition>
    <arm_group>
      <arm_group_label>Intradiscal Gelified Ethanol Arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients who come with symptomatic cervical disc herniation or with cervical discogenic pain and meet the eligibility criteria.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Intradiscal Gelified Ethanol</intervention_name>
      <description>Intradiscal percutaneous injection of an intradiscal Gelified Ethanol</description>
      <arm_group_label>Intradiscal Gelified Ethanol Arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient 18 years or older;&#xD;
  &#xD;
            -  Pain refractory to conservative treatments for more than 2 months, non-surgical&#xD;
               patients&#xD;
  &#xD;
            -  Cervicobrachialgia due to disc herniation&#xD;
  &#xD;
            -  Chronic discogenic pain (1 or 2 cervical discs) with concordant MRI;&#xD;
  &#xD;
            -  Patient agreeing to participate in the study and having given written consent;&#xD;
  &#xD;
            -  Patient enrolled in a health insurance plan.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior surgical treatment of the disc(s) studied;&#xD;
  &#xD;
            -  Sick leave of more than 12 months secondary to painful symptoms;&#xD;
  &#xD;
            -  Patient with Modic 1 score or more&#xD;
  &#xD;
            -  History of cognitive-behavioral disorders that could affect the completion of&#xD;
               self-questionnaires;&#xD;
  &#xD;
            -  Local or systemic infection, or suspicion of infection;&#xD;
  &#xD;
            -  Severe coagulation disorders;&#xD;
  &#xD;
            -  Other inflammatory rheumatic disease;&#xD;
  &#xD;
            -  Severe underlying pathology with life expectancy &lt;1 year;&#xD;
  &#xD;
            -  Women of childbearing age who are pregnant at the inclusion visit or who wish to&#xD;
               become pregnant before the administration of the treatment (V0);&#xD;
  &#xD;
            -  Known allergy to contrast material and/or local anesthetic substances;&#xD;
  &#xD;
            -  Patients who cannot read or write Italian;&#xD;
  &#xD;
            -  Major person benefiting from a legal protection regime (guardianship, curatorship,&#xD;
               safeguard of justice);&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>120 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Santissima Trinità Hospital Ascagliari</name>
        <address>
          <city>Cagliari</city>
          <zip>9121</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Stefano Marcia, Pr</last_name>
        <email>stemarcia@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Azienda Ospedaliera Universitaria</name>
        <address>
          <city>Siena</city>
          <zip>53000</zip>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Matteo Bellini, Dr</last_name>
        <email>matteo.bellini@icloud.com</email>
      </contact>
      <contact_backup>
        <last_name>Chiara Zini</last_name>
        <email>zini.chiara@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</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>Neck Pain</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ethanol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Confidential data (Pre-market Study trial)</ipd_description>
    </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/NCT05969392
  org study id: CLI01068
  nct id: NCT05969392
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to assesse safety and efficacy of the Intradiscal Gelified
        Ethanol for treatment in refractory cervical discogenic pain.
  After being informed about the study and potential tisks, all patients giving written
        informed consent will undergo a inclusion visit (CT scan and X ray at least) for study entry.
        At Day 0, operation with Intradiscal Gelified Ethanol will be performed by the investigator.
        Follow visit will be performed at 3 months and 12 months
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: the mean change in pain intensity assessed by a verbal local rating scale (pain intensity numerical scale) between the pre-treatment measurement (inclusion visi) and the post-treatment measurement (Visit 2 at the 3 months)
  time frame: 3 months
  description: In a 11-point numeric scale, 0 represents "NO PAIN" and 10 represents "EXTREME PAIN" (e.g., "pain as bad as you can imagine" and "worst pain imaginable").
  measure: Change in pain cervical intensity using the verbal local rating scale [
  time frame: 12 months
  description: Scores range from 0-10. In a 11-point numeric scale, 0 represents "NO PAIN" and 10 represents "EXTREME PAIN" (e.g., "pain as bad as you can imagine" and "worst pain imaginable").
  measure: Change of consumption of painkillers
  time frame: 12 months
  description: Number, frequency and dosage of pain relief treatments will be combine todescribe the difference in painkiller consumption before and after the operation
  measure: Incidence of complication and adverse event rates
  time frame: 12 months
  description: Incidence of adverse event during 12 months after the treatment
  measure: Change in ability to manage everyday-life activity (Neck Disability Index (NDI) scale) [Time Frame : inclusion, 3 and 12 months after treatment].
  time frame: 12 months
  description: The Neck Disability Index (NDI) is used to measure pain-related disability associated with activities of daily living in people with neck pain (index between 0 and 50). The original report provided scoring intervals for interpretation, as follows: 0 - 4 = no disability, 5 - 14 = mild, 15 - 24 = moderate, 25 - 34 = severe, above 34 = complete. The NDI contains 10 items-7 related to activities of daily living, 2 related to pain, and 1 related to concentration.
  measure: Subjective evaluation MacNab
  time frame: 12 months after treatment
  description: The MacNab's scale is layered into 4 levels (excellent, good, fair and poor) according to the patient's well-being after surgery or procedure.The scores were divided into the following four grades: 75-100% (excellent), 50-74% (good), 25-49% (fair) and 0-24% (poor). "Excellent" is defined as "No pain; no restriction of activity". "Good" is defined as "Occasional pain of sufficient severity to interfere with the patient's ability to do his normal work or his capacity to enjoy himself in leisure hours".
  arm group label: Intradiscal Gelified Ethanol Arm
  arm group type: Experimental
  description: Patients who come with symptomatic cervical disc herniation or with cervical discogenic pain and meet the eligibility criteria.
  intervention type: Device
  intervention name: Intradiscal Gelified Ethanol
  description: Intradiscal percutaneous injection of an intradiscal Gelified Ethanol
  arm group label: Intradiscal Gelified Ethanol Arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 120 Years
  healthy volunteers: No
  facility: 
  contact: 
  facility: 
  contact: 
  contact backup: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Neck Pain
  mesh term: Ethanol
  sharing ipd: No
  ipd description: Confidential data (Pre-market Study trial)