<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/NCT04469738</url>
  </required_header>
  <id_info>
    <org_study_id>NOSE</org_study_id>
    <nct_id>NCT04469738</nct_id>
  </id_info>
  <brief_title>Evaluating a Treatment Effect in Patients With FBSS Using an Electronic Nose: a Pilot Study</brief_title>
  <acronym>NOSE</acronym>
  <official_title>Evaluating a Treatment Effect in Patients With FBSS Using an Electronic Nose: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>the eNose company</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>
      This study is an experimental single-center pilot study investigating Volatile Organic&#xD;
      Compounds patterns in exhaled breath during on and off states of SCS, in patient with Failed&#xD;
      Back Surgery Syndrome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2020</start_date>
  <completion_date type="Actual">March 27, 2021</completion_date>
  <primary_completion_date type="Actual">March 27, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exhaled breath changes</measure>
    <time_frame>Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.</time_frame>
    <description>The investigators will examine the difference in exhaled breath patterns between both measurements (SCS on versus SCS off), measured with the Aeonose.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity scores using the Visual Analogue Scale</measure>
    <time_frame>Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.</time_frame>
    <description>Pain intensity score on that time on a Visual Analogue Scale (VAS) ranging from zero (no pain) towards 10 (worst possible pain) for the pain intensity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Failed Back Surgery Syndrome</condition>
  <arm_group>
    <arm_group_label>SCS off</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>SCS on</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SCS is switched off</intervention_name>
    <description>Spinal cord stimulator is switched off for 12 hours</description>
    <arm_group_label>SCS off</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SCS is switched on</intervention_name>
    <description>Spinal cord stimulator is functioning</description>
    <arm_group_label>SCS on</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of FBSS (Failed conservative treatments for pain including but not limited&#xD;
             to pharmacological therapy and physical therapy) and currently being treated with&#xD;
             spinal cord stimulation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a diagnosis of cancer.&#xD;
&#xD;
          -  Patients with major psychiatric problems.&#xD;
&#xD;
          -  Patients with an underlying respiratory disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maarten Moens, Prof. dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitair Ziekenhuis Brussel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Brussel</name>
      <address>
        <city>Jette</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>May 20, 2021</last_update_submitted>
  <last_update_submitted_qc>May 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Failed Back Surgery Syndrome</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/NCT04469738
org study id: NOSE
nct id: NCT04469738
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study is an experimental single-center pilot study investigating Volatile Organic
      Compounds patterns in exhaled breath during on and off states of SCS, in patient with Failed
      Back Surgery Syndrome.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Exhaled breath changes
time frame: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.
description: The investigators will examine the difference in exhaled breath patterns between both measurements (SCS on versus SCS off), measured with the Aeonose.
measure: Pain intensity scores using the Visual Analogue Scale
time frame: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.
description: Pain intensity score on that time on a Visual Analogue Scale (VAS) ranging from zero (no pain) towards 10 (worst possible pain) for the pain intensity.
arm group label: SCS off
arm group type: Experimental
arm group label: SCS on
arm group type: Experimental
intervention type: Device
intervention name: SCS is switched off
description: Spinal cord stimulator is switched off for 12 hours
arm group label: SCS off
intervention type: Device
intervention name: SCS is switched on
description: Spinal cord stimulator is functioning
arm group label: SCS on
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maarten Moens, Prof. dr.
role: Principal Investigator
affiliation: Universitair Ziekenhuis Brussel
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universitair Ziekenhuis Brussel
investigator full name: Moens Maarten
investigator title: principal investigator
mesh term: Failed Back Surgery Syndrome