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/NCT06030635</url>
    </required_header>
    <id_info>
      <org_study_id>1056</org_study_id>
      <nct_id>NCT06030635</nct_id>
    </id_info>
    <brief_title>ACS Monitoring Charité Berlin</brief_title>
    <official_title>Non-invasive Monitoring of Patients at Risk of Acute Compartment Syndrome (ACS) With CPMX1</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Compremium AG</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Compremium AG</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Compartment syndrome is a very serious musculoskeletal disorder, which can lead to&#xD;
        devastating consequences, such as limb amputation and life-threatening conditions. It is a&#xD;
        well described medical condition considered to be an orthopaedic emergency affecting all&#xD;
        ages.&#xD;
  &#xD;
        In the diagnosis of acute compartment syndrome, clinical suspicion supplemented by careful,&#xD;
        repeated clinical examination continues to be the clinician's greatest tool. The classic&#xD;
        signs and symptoms of acute compartment pressure are often listed as the 5 or 6 &quot;Ps&quot;: Pain,&#xD;
        Pressure, Pulselessness, Paralysis, Paresthesia, and Pallor. The diagnosis is typically not&#xD;
        made by using equipment and it is difficult in the awake and oriented patient, becoming even&#xD;
        more problematic in the polytrauma patient.&#xD;
  &#xD;
        An alternative diagnostic method for compartment syndrome is invasive intra-compartmental&#xD;
        pressure measurement via insertion of a pressure monitoring device into the muscle&#xD;
        compartment. However, literature shows that commercially available intra compartmental&#xD;
        pressure monitors have a highly variable intra-observer reproducibility and that user errors&#xD;
        are common.&#xD;
  &#xD;
        Compared to the invasive modalities or just experience of the surgeon, the CPMX1 shows&#xD;
        promising advantages for the clinical application. Not only is the technology used for the&#xD;
        CPMX1 device safe and non-invasive for the patient with only initial training required for&#xD;
        the healthcare professionals, but it has also demonstrated high intra- and inter-observer&#xD;
        reproducibility (as per bench tests and confirmed in clinical setting). Recently, two&#xD;
        clinical studies (&quot;SWISS_EVIDENCE&quot; and &quot;SWISS_CLEARANCE&quot;) were conducted using the CPMX1 in&#xD;
        healthy volunteers in a real-world clinical environment. Results of these studies confirmed&#xD;
        that the application of the CMPX1 in patient care is safe and validated the reliability of&#xD;
        compressibility ratio measurement with the CPMX1 in healthy volunteers.&#xD;
  &#xD;
        The use of the CPMX1 device therefore facilitates the measurements, as it is based on pre-&#xD;
        existing ultrasound methods, and avoids any further risks to the patients compared to&#xD;
        invasive compartmental pressure diagnosis methods.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">December 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 15, 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>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Lowest CP Values [percent] (highest compartmental pressure)</measure>
      <time_frame>During the procedure which will last 8 hours/patient</time_frame>
      <description>Lowest CP Values [percent] (highest compartmental pressure) will be assessed from the difference in CP Values [percent] using the CPMX1 for a compartment at risk of ACS and compartment not at risk of ACS at the same time, contrasted by a pairwise t-test.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>CP Value [percent] trend over time</measure>
      <time_frame>During the procedure which will last 8 hours/patient</time_frame>
      <description>Each study patient will be monitored every hour for a total of 8 hours with the investigational device. The CP Value [percent] trend over time will be visualized per patient through plots.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CP Values [percent] from the compartments at risk of ACS and CP Values [percent] of compartment not at risk at the same time.</measure>
      <time_frame>During the procedure which will last 8 hours/patient</time_frame>
      <description>CP Value [percent] of extremities at risk and not at risk of ACS will be contrasted by a pairwise t-test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quotient CP Value [percent]</measure>
      <time_frame>During the procedure which will last 8 hours/patient</time_frame>
      <description>Quotient calculation will be performed between CP Value of affected and non-affected limb's compartment. Values will be contrasted between the groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time of the lowest CP Values [percent] (highest compartmental pressure) for the compartment at risk of ACS</measure>
      <time_frame>During the procedure which will last 8 hours/patient</time_frame>
      <description>The mean time point for lowest CP Values [percent] and range will be calculated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Usability and workflow assessment</measure>
      <time_frame>At the end of the participation of each investigator to the clinical study (up to 3 months)</time_frame>
      <description>Usability and workflow assessment will be evaluated through a practitioner's questionnaire which will be filled by each investigator at the end of the participation in the clinical investigation. The questionnaire will cover different aspects regarding usability and safety of the CPMX1 device.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Assessment of adverse events</measure>
      <time_frame>During the procedure which will last 8 hours/patient</time_frame>
      <description>Safety of the device will be assessed by systematically reporting adverse events and serious adverse events (description, severity, relation to the procedure) and by monitoring the frequency and incidence of these events.</description>
    </other_outcome>
    <other_outcome>
      <measure>Assessment of device deficiencies</measure>
      <time_frame>During the procedure which will last 8 hours/patient</time_frame>
      <description>Safety of the device will be assessed by systematically reporting device deficiencies (description of the deficiency) and by monitoring the frequency and incidence of these events</description>
    </other_outcome>
    <other_outcome>
      <measure>New risk identification</measure>
      <time_frame>At the end of the participation of each investigator to the clinical study (up to 3 months)</time_frame>
      <description>The practitioner will be asked to identify any new risks arising when using the investigational device.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Compartment Syndromes</condition>
    <arm_group>
      <arm_group_label>CPMX1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Compartment compressibility measurement using the CPMX1 device</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Measurement of compartment compressibility using the CPMX1 device</intervention_name>
      <description>Patients will be monitored every hour for a total of 8 hours. At each time point, three measurements of compartment compressibility will be conducted using the CMPX1 on both the affected (potential ACS) and healthy limb.</description>
      <arm_group_label>CPMX1</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients able to give consent&#xD;
  &#xD;
            -  Informed consent documented by signature&#xD;
  &#xD;
            -  Potential acute compartment syndrome (ACS) of the extremities (excl. hands, feet)&#xD;
  &#xD;
            -  Male or female&#xD;
  &#xD;
            -  Age 18 to 95 years&#xD;
  &#xD;
            -  Intact skin at the measurement site&#xD;
  &#xD;
            -  Open fracture up to Grade I if not in the measurement area&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Potential Acute Compartment Syndrome (ACS) of both extremities considered&#xD;
  &#xD;
            -  Limb anomalies that could hinder the measurement&#xD;
  &#xD;
            -  Individuals who are deprived of liberty pursuant to an administrative order or court&#xD;
               order or approval.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>95 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tobias Gehlen, Dr med</last_name>
      <role>Principal Investigator</role>
      <affiliation>Centrum für Muskuloskeletale Chirurgie Charité - Universitätmedizin Berlin</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Vincent Baumann</last_name>
      <phone>+41 79 933 96 48</phone>
      <email>v.baumann@compremium.ch</email>
    </overall_contact>
    <location>
      <facility>
        <name>Centrum für Muskuloskeletale Chirurgie Charité - Universitätmedizin Berlin</name>
        <address>
          <city>Berlin</city>
          <zip>13353</zip>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>Tobias Gehlen, Dr med</last_name>
        <phone>030 450 652689</phone>
        <email>tobias.gehlen@charite.de</email>
      </contact>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 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>Compartment Syndromes</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06030635
  org study id: 1056
  nct id: NCT06030635
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Compartment syndrome is a very serious musculoskeletal disorder, which can lead to
        devastating consequences, such as limb amputation and life-threatening conditions. It is a
        well described medical condition considered to be an orthopaedic emergency affecting all
        ages.
  
        In the diagnosis of acute compartment syndrome, clinical suspicion supplemented by careful,
        repeated clinical examination continues to be the clinician's greatest tool. The classic
        signs and symptoms of acute compartment pressure are often listed as the 5 or 6 "Ps": Pain,
        Pressure, Pulselessness, Paralysis, Paresthesia, and Pallor. The diagnosis is typically not
        made by using equipment and it is difficult in the awake and oriented patient, becoming even
        more problematic in the polytrauma patient.
  
        An alternative diagnostic method for compartment syndrome is invasive intra-compartmental
        pressure measurement via insertion of a pressure monitoring device into the muscle
        compartment. However, literature shows that commercially available intra compartmental
        pressure monitors have a highly variable intra-observer reproducibility and that user errors
        are common.
  
        Compared to the invasive modalities or just experience of the surgeon, the CPMX1 shows
        promising advantages for the clinical application. Not only is the technology used for the
        CPMX1 device safe and non-invasive for the patient with only initial training required for
        the healthcare professionals, but it has also demonstrated high intra- and inter-observer
        reproducibility (as per bench tests and confirmed in clinical setting). Recently, two
        clinical studies ("SWISS_EVIDENCE" and "SWISS_CLEARANCE") were conducted using the CPMX1 in
        healthy volunteers in a real-world clinical environment. Results of these studies confirmed
        that the application of the CMPX1 in patient care is safe and validated the reliability of
        compressibility ratio measurement with the CPMX1 in healthy volunteers.
  
        The use of the CPMX1 device therefore facilitates the measurements, as it is based on pre-
        existing ultrasound methods, and avoids any further risks to the patients compared to
        invasive compartmental pressure diagnosis methods.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Lowest CP Values [percent] (highest compartmental pressure)
  time frame: During the procedure which will last 8 hours/patient
  description: Lowest CP Values [percent] (highest compartmental pressure) will be assessed from the difference in CP Values [percent] using the CPMX1 for a compartment at risk of ACS and compartment not at risk of ACS at the same time, contrasted by a pairwise t-test.
  measure: CP Value [percent] trend over time
  time frame: During the procedure which will last 8 hours/patient
  description: Each study patient will be monitored every hour for a total of 8 hours with the investigational device. The CP Value [percent] trend over time will be visualized per patient through plots.
  measure: CP Values [percent] from the compartments at risk of ACS and CP Values [percent] of compartment not at risk at the same time.
  time frame: During the procedure which will last 8 hours/patient
  description: CP Value [percent] of extremities at risk and not at risk of ACS will be contrasted by a pairwise t-test.
  measure: Quotient CP Value [percent]
  time frame: During the procedure which will last 8 hours/patient
  description: Quotient calculation will be performed between CP Value of affected and non-affected limb's compartment. Values will be contrasted between the groups.
  measure: Time of the lowest CP Values [percent] (highest compartmental pressure) for the compartment at risk of ACS
  time frame: During the procedure which will last 8 hours/patient
  description: The mean time point for lowest CP Values [percent] and range will be calculated.
  measure: Usability and workflow assessment
  time frame: At the end of the participation of each investigator to the clinical study (up to 3 months)
  description: Usability and workflow assessment will be evaluated through a practitioner's questionnaire which will be filled by each investigator at the end of the participation in the clinical investigation. The questionnaire will cover different aspects regarding usability and safety of the CPMX1 device.
  measure: Assessment of adverse events
  time frame: During the procedure which will last 8 hours/patient
  description: Safety of the device will be assessed by systematically reporting adverse events and serious adverse events (description, severity, relation to the procedure) and by monitoring the frequency and incidence of these events.
  measure: Assessment of device deficiencies
  time frame: During the procedure which will last 8 hours/patient
  description: Safety of the device will be assessed by systematically reporting device deficiencies (description of the deficiency) and by monitoring the frequency and incidence of these events
  measure: New risk identification
  time frame: At the end of the participation of each investigator to the clinical study (up to 3 months)
  description: The practitioner will be asked to identify any new risks arising when using the investigational device.
  arm group label: CPMX1
  arm group type: Experimental
  description: Compartment compressibility measurement using the CPMX1 device
  intervention type: Device
  intervention name: Measurement of compartment compressibility using the CPMX1 device
  description: Patients will be monitored every hour for a total of 8 hours. At each time point, three measurements of compartment compressibility will be conducted using the CMPX1 on both the affected (potential ACS) and healthy limb.
  arm group label: CPMX1
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 95 Years
  healthy volunteers: No
  last name: Tobias Gehlen, Dr med
  role: Principal Investigator
  affiliation: Centrum für Muskuloskeletale Chirurgie Charité - Universitätmedizin Berlin
  last name: Vincent Baumann
  phone: +41 79 933 96 48
  email: v.baumann@compremium.ch
  facility: 
  contact: 
  country: Germany
  responsible party type: Sponsor
  mesh term: Compartment Syndromes
  mesh term: Syndrome
  sharing ipd: No