<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/NCT04418583</url>
  </required_header>
  <id_info>
    <org_study_id>METCZ20200071</org_study_id>
    <nct_id>NCT04418583</nct_id>
  </id_info>
  <brief_title>Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging</brief_title>
  <acronym>CRANE</acronym>
  <official_title>Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zuyderland Medisch Centrum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zuyderland Medisch Centrum</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>
      Pectus excavatum is the most common congenital abnormality of the thoracic wall and occurs in&#xD;
      1 in 400 newborns. The gold standard treatment is the Nuss bar Procedure. However, in very&#xD;
      severe cases, pectus exacavatum involves little or no space between the heart and sternum.&#xD;
      Because of the limited space, the Nuss procedure is more difficult to perform and there is an&#xD;
      increased risk of complications such as injuries to the heart or large vessels. However, this&#xD;
      increased risk can again be reduced by using the Crane technique. This technique increases&#xD;
      the substernal space by sternal 'hoisting' via an external steel wire. Despite the fact that&#xD;
      this technique is commonly used, it is not known what its quantitative effect is on the&#xD;
      substernal space during the Nuss bar procedure. The subsequent aim of this study is to&#xD;
      quantify the effect of the Crane technique during minimally invasive repair of pectus&#xD;
      excavatum through three-dimensional scans acquired before and after application of the Crane&#xD;
      technique.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 13, 2020</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Anticipated">March 2021</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>Prospective case-control study wherein participants are their own control</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in chest wall dimensions</measure>
    <time_frame>1 hour</time_frame>
    <description>difference between baseline (first image) and image after application of the Crane technique</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Pectus Excavatum</condition>
  <condition>Funnel Chest</condition>
  <arm_group>
    <arm_group_label>Three-dimensional imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive a three-dimensional image of their chest, just prior to and after application of the Crane technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Three-dimensional imaging</intervention_name>
    <description>Three-dimensional surface images, acquired by the Artec Leo</description>
    <arm_group_label>Three-dimensional imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing minimally invasive repair of pectus excavatum (through the Nuss bar&#xD;
             procedure) in conjunction with the Crane technique.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zuyderland Medical Centre</name>
      <address>
        <city>Heerlen</city>
        <state>Limburg</state>
        <zip>6419PC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean Daemen</last_name>
      <phone>+314597777</phone>
      <email>j.daemen@zuyderland.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</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>Funnel Chest</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/NCT04418583
org study id: METCZ20200071
nct id: NCT04418583
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pectus excavatum is the most common congenital abnormality of the thoracic wall and occurs in
      1 in 400 newborns. The gold standard treatment is the Nuss bar Procedure. However, in very
      severe cases, pectus exacavatum involves little or no space between the heart and sternum.
      Because of the limited space, the Nuss procedure is more difficult to perform and there is an
      increased risk of complications such as injuries to the heart or large vessels. However, this
      increased risk can again be reduced by using the Crane technique. This technique increases
      the substernal space by sternal 'hoisting' via an external steel wire. Despite the fact that
      this technique is commonly used, it is not known what its quantitative effect is on the
      substernal space during the Nuss bar procedure. The subsequent aim of this study is to
      quantify the effect of the Crane technique during minimally invasive repair of pectus
      excavatum through three-dimensional scans acquired before and after application of the Crane
      technique.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective case-control study wherein participants are their own control
primary purpose: Basic Science
masking: None (Open Label)
measure: Mean change in chest wall dimensions
time frame: 1 hour
description: difference between baseline (first image) and image after application of the Crane technique
arm group label: Three-dimensional imaging
arm group type: Experimental
description: Participants receive a three-dimensional image of their chest, just prior to and after application of the Crane technique.
intervention type: Diagnostic Test
intervention name: Three-dimensional imaging
description: Three-dimensional surface images, acquired by the Artec Leo
arm group label: Three-dimensional imaging
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Netherlands
responsible party type: Sponsor
mesh term: Funnel Chest
sharing ipd: Undecided