<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/NCT03840434</url>
  </required_header>
  <id_info>
    <org_study_id>2019-A00141-56</org_study_id>
    <nct_id>NCT03840434</nct_id>
  </id_info>
  <brief_title>COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure</brief_title>
  <acronym>COLONIA</acronym>
  <official_title>COmpartment Syndrome vaLidation Of Non Invasive Assessment of Tissue Pressure (COLONIA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</source>
  <oversight_info>
    <has_dmc>No</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>
      Chronic Compartment Syndrome (CCS) is a pathology that affects more specifically subjects&#xD;
      exposed to repeated movements, particularly in a professional life or sports. The diagnosis&#xD;
      is difficult and often delayed.&#xD;
&#xD;
      Currently, the reference technique is invasive. It consists of measuring by a intramuscular&#xD;
      puncture (IMP) pressure in the offending compartment early after effort (usually between 1&#xD;
      and 5 minutes post-exercise). A value greater than or equal to 30 mmHg in the first 5 minutes&#xD;
      is used as a diagnostic criterion for CCS.&#xD;
&#xD;
      Other less invasive techniques (scintigraphy) exist but are subject to certain discordances&#xD;
      of interpretation. The advent of new assessment tools, like the MyotonPRO, pave the way for a&#xD;
      non-invasive diagnostic approach.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients referred for suspected chronic compartment syndrome causing will be included.&#xD;
&#xD;
      After signing the consent, the subject will have a clinical and paraclinical examination.&#xD;
      Age, sex, height, weight, side of clinical symptomatology will be collected. Medical history&#xD;
      current treatments will also be noted. Once the consent is collected, the patient performs,&#xD;
      according to the data of the literature and service habits a stress test aimed at triggering&#xD;
      the painful symptomatology associated with post-exercise IMP and MyotonPRO measurements as&#xD;
      the same time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2019</start_date>
  <completion_date type="Actual">March 27, 2023</completion_date>
  <primary_completion_date type="Actual">March 27, 2023</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Each patient will perform a stress test to trigger the painful. Measurements will be done by intramuscular punction as usually, and by non invasive tool : MyotonPRO.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic performance of MyotonPRO</measure>
    <time_frame>3 years</time_frame>
    <description>To study the diagnostic performance of tissue stiffness measurement by MyotonPRO at 1 minute post-exercise in patients suspected of anterolateral of leg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diagnostic performance of MyotonPRO at 1 minute post-exercise</measure>
    <time_frame>3 years</time_frame>
    <description>To study the diagnostic performance of the MyotonPRO tissue stiffness measurement variation between rest and 1 minute post-exercise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diagnostic performance of MyotonPRO at 5 minute post-exercise</measure>
    <time_frame>3 years</time_frame>
    <description>To study the diagnostic performance of the MyotonPRO tissue stiffness measurement variation between rest and 5 minute post-exercise.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Compartment Syndrome</condition>
  <arm_group>
    <arm_group_label>CCS group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Measurements by intramuscular punction and non invasive tool</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MyotonPRO</intervention_name>
    <description>Each patient will perform a stress test to trigger the painful. Measurements will be done by intramuscular punction as usually, and by non invasive tool : MyotonPRO</description>
    <arm_group_label>CCS group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Affiliation to the French National healthcare system&#xD;
&#xD;
          -  French speaking patients&#xD;
&#xD;
          -  Referred for investigation of compartment syndrome causing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Inability to understand the study goal&#xD;
&#xD;
          -  Patients protected by decision of law&#xD;
&#xD;
          -  Extended dermatosis&#xD;
&#xD;
          -  Coagulation disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antoine BRUNEAU, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UH Angers</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre hospitalier universitaire</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>compartment syndrome</keyword>
  <keyword>intramuscular punction Versus non invasive assessment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Compartment Syndromes</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03840434
org study id: 2019-A00141-56
nct id: NCT03840434
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chronic Compartment Syndrome (CCS) is a pathology that affects more specifically subjects
      exposed to repeated movements, particularly in a professional life or sports. The diagnosis
      is difficult and often delayed.

      Currently, the reference technique is invasive. It consists of measuring by a intramuscular
      puncture (IMP) pressure in the offending compartment early after effort (usually between 1
      and 5 minutes post-exercise). A value greater than or equal to 30 mmHg in the first 5 minutes
      is used as a diagnostic criterion for CCS.

      Other less invasive techniques (scintigraphy) exist but are subject to certain discordances
      of interpretation. The advent of new assessment tools, like the MyotonPRO, pave the way for a
      non-invasive diagnostic approach.
Patients referred for suspected chronic compartment syndrome causing will be included.

      After signing the consent, the subject will have a clinical and paraclinical examination.
      Age, sex, height, weight, side of clinical symptomatology will be collected. Medical history
      current treatments will also be noted. Once the consent is collected, the patient performs,
      according to the data of the literature and service habits a stress test aimed at triggering
      the painful symptomatology associated with post-exercise IMP and MyotonPRO measurements as
      the same time.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Each patient will perform a stress test to trigger the painful. Measurements will be done by intramuscular punction as usually, and by non invasive tool : MyotonPRO.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic performance of MyotonPRO
time frame: 3 years
description: To study the diagnostic performance of tissue stiffness measurement by MyotonPRO at 1 minute post-exercise in patients suspected of anterolateral of leg
measure: Diagnostic performance of MyotonPRO at 1 minute post-exercise
time frame: 3 years
description: To study the diagnostic performance of the MyotonPRO tissue stiffness measurement variation between rest and 1 minute post-exercise.
measure: Diagnostic performance of MyotonPRO at 5 minute post-exercise
time frame: 3 years
description: To study the diagnostic performance of the MyotonPRO tissue stiffness measurement variation between rest and 5 minute post-exercise.
arm group label: CCS group
arm group type: Other
description: Measurements by intramuscular punction and non invasive tool
intervention type: Diagnostic Test
intervention name: MyotonPRO
description: Each patient will perform a stress test to trigger the painful. Measurements will be done by intramuscular punction as usually, and by non invasive tool : MyotonPRO
arm group label: CCS group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antoine BRUNEAU, PhD
role: Principal Investigator
affiliation: UH Angers
facility: 
country: France
responsible party type: Sponsor
mesh term: Compartment Syndromes
mesh term: Syndrome
sharing ipd: Undecided