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/NCT06030973</url>
    </required_header>
    <id_info>
      <org_study_id>PROLOGUE</org_study_id>
      <nct_id>NCT06030973</nct_id>
    </id_info>
    <brief_title>Opinions of Healthcare Providers About a European Neuromodulation Register</brief_title>
    <official_title>Opinions of Healthcare Providers About a European Neuromodulation Register: an Online Survey</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Moens Maarten</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Vrije Universiteit Brussel</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Universitair Ziekenhuis Brussel</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this online survey is to gain further insights in the needs and burden for a&#xD;
        European registry for neuromodulation, according to healthcare providers.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 31, 2023</start_date>
    <completion_date type="Anticipated">September 2, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Healthcare providers their current degree of participation in a registry for neuromodulation.</measure>
      <time_frame>Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023.</time_frame>
      <description>Degree of participation in a registry for neuromodulation (question).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Healthcare providers their need for a European registry.</measure>
      <time_frame>Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023.</time_frame>
      <description>Underlying reasons on why a European registry is needed, or not needed (question).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Items that should be included in a registry for neuromodulation, according to healthcare providers.</measure>
      <time_frame>Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023.</time_frame>
      <description>Items that should be collection within a registry, evaluated with a multiple choice question.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Access regulations to European registry for neuromodulation, according to healthcare providers.</measure>
      <time_frame>Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023.</time_frame>
      <description>Access regulations, evaluated with a multiple choice question.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Registry</condition>
    <condition>Neuromodulation</condition>
    <condition>Survey</condition>
    <arm_group>
      <arm_group_label>Healthcare professionals involved in neuromodulation</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Filling in an online survey</intervention_name>
      <description>Professionals are asked to complete questions regarding 1) the degree of current participation in a registry, 2) the need for a European registry, 3) the items that should be collected and 4) access to the European registry.</description>
      <arm_group_label>Healthcare professionals involved in neuromodulation</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          In this study male and female adults who are involved in the management of chronic pain and&#xD;
          more specifically in neuromodulation for pain (including but not limited to&#xD;
          anesthesiologists, neurosurgeons, nurses) will be eligible to complete the survey. The&#xD;
          survey will be spread at the 3ʳᵈ Joint Congress of the INS European Chapters (e-INS 2023)&#xD;
          in Hamburg from 31/8/2023 to 2/9/2023.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and female adults who are involved in the management of chronic pain and more&#xD;
               specifically in neuromodulation for pain (including but not limited to&#xD;
               anesthesiologists, neurosurgeons, nurses).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not involved in management of chronic pain through neuromodulation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Maarten Moens</last_name>
      <phone>+3224775514</phone>
      <email>stimulusresearchgroup@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lisa Goudman</last_name>
      <phone>+3224775514</phone>
      <email>stimulusresearchgroup@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Congres Center</name>
        <address>
          <city>Hamburg</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maarten Moens</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Universitair Ziekenhuis Brussel</investigator_affiliation>
      <investigator_full_name>Moens Maarten</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <!-- 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/NCT06030973
  org study id: PROLOGUE
  nct id: NCT06030973
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this online survey is to gain further insights in the needs and burden for a
        European registry for neuromodulation, according to healthcare providers.
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Healthcare providers their current degree of participation in a registry for neuromodulation.
  time frame: Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023.
  description: Degree of participation in a registry for neuromodulation (question).
  measure: Healthcare providers their need for a European registry.
  time frame: Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023.
  description: Underlying reasons on why a European registry is needed, or not needed (question).
  measure: Items that should be included in a registry for neuromodulation, according to healthcare providers.
  time frame: Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023.
  description: Items that should be collection within a registry, evaluated with a multiple choice question.
  measure: Access regulations to European registry for neuromodulation, according to healthcare providers.
  time frame: Cross-sectional evaluation during 3th Joint Congress of the INS European Chapters (e-INS 2023) in Hamburg in August-September 2023.
  description: Access regulations, evaluated with a multiple choice question.
  arm group label: Healthcare professionals involved in neuromodulation
  intervention type: Behavioral
  intervention name: Filling in an online survey
  description: Professionals are asked to complete questions regarding 1) the degree of current participation in a registry, 2) the need for a European registry, 3) the items that should be collected and 4) access to the European registry.
  arm group label: Healthcare professionals involved in neuromodulation
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Maarten Moens
  phone: +3224775514
  email: stimulusresearchgroup@gmail.com
  last name: Lisa Goudman
  phone: +3224775514
  email: stimulusresearchgroup@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Germany
  responsible party type: Sponsor-Investigator
  investigator affiliation: Universitair Ziekenhuis Brussel
  investigator full name: Moens Maarten
  investigator title: Principal Investigator