<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/NCT04452721</url>
  </required_header>
  <id_info>
    <org_study_id>20CH030</org_study_id>
    <nct_id>NCT04452721</nct_id>
  </id_info>
  <brief_title>Prognosis Factors for the Treatment of Pectus Carinatum With a Dynamic Compression System</brief_title>
  <acronym>Pectusdyn</acronym>
  <official_title>Prognosis Factors for the Treatment of Pectus Carinatum With a Dynamic Compression System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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 carinatum is a deformation of the thoracic wall causing an aesthetic prejudice. Since&#xD;
      2011, our team uses a dynamic compression system to treat this deformation. It is a harness&#xD;
      that the patient wears all day long for an average duration of 1 year, and that remodels the&#xD;
      chest by exerting a moderate pressure on it. The local cohort is one of the largest in the&#xD;
      world. The few previous publications have shown the validity of this method, but the&#xD;
      prognosis factors for success of this innovative treatment are not yet identified.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The principal insvestigator hypothesizes that the success or failure of the treatment depends&#xD;
      on several parameters assessable before treatment, such as the patient's age, gender, initial&#xD;
      correction pressure, symmetry or not of the deformation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Decrease of the deformation of more than 50% (measured in mm) after 6 months of treatment</measure>
    <time_frame>After 6 months of treatment</time_frame>
    <description>Dynamic compression system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Failure of treatment assessed by the patient, ie if the patients considers the treatment to have failed, if he choose to underwent surgery afterwards, or if he considered the pectus carinatum to have relapsed</measure>
    <time_frame>After the end of treatment (6 months to 2 years)</time_frame>
    <description>Dynamic compression system</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">520</enrollment>
  <condition>Pectus Carinatum</condition>
  <arm_group>
    <arm_group_label>Retrospective cohort</arm_group_label>
    <description>340 to 400 patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Validation cohort</arm_group_label>
    <description>120 patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>dynamic compression system</intervention_name>
    <description>It is a harness that the patient wears all day long for an average duration of 1 year, and that remodels the chest by exerting a moderate pressure on it</description>
    <arm_group_label>Retrospective cohort</arm_group_label>
    <arm_group_label>Validation cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Refusal to participate to this treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who received proper information about the study.&#xD;
&#xD;
          -  Patient with clinically diagnosed pectus carinatum.&#xD;
&#xD;
          -  Treated at Saint-Etienne University Hospital using a dynamic compression system.&#xD;
&#xD;
          -  Between October 2011 and January 2020 for the retrospective part, then between January&#xD;
             2020 and January 2022 for the validation cohort.&#xD;
&#xD;
          -  With more than 6 months of follow-up since the beginning of the treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aurélien SCALABRE</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Saint-Etienne</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aurélien SCALABRE</last_name>
    <phone>04 77 82 94 49</phone>
    <email>aurelien.scalabre@chu-etienne.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Saint-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aurélien SCALABRE</last_name>
      <phone>0477829449</phone>
      <email>aurelien.scalabre@chu-st-etienne.fr</email>
    </contact>
    <investigator>
      <last_name>Aurélien SCALABRE</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>May 16, 2023</last_update_submitted>
  <last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pectus Carinatum</keyword>
  <keyword>Dynamic compression system</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pectus Carinatum</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04452721
org study id: 20CH030
nct id: NCT04452721
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pectus carinatum is a deformation of the thoracic wall causing an aesthetic prejudice. Since
      2011, our team uses a dynamic compression system to treat this deformation. It is a harness
      that the patient wears all day long for an average duration of 1 year, and that remodels the
      chest by exerting a moderate pressure on it. The local cohort is one of the largest in the
      world. The few previous publications have shown the validity of this method, but the
      prognosis factors for success of this innovative treatment are not yet identified.
The principal insvestigator hypothesizes that the success or failure of the treatment depends
      on several parameters assessable before treatment, such as the patient's age, gender, initial
      correction pressure, symmetry or not of the deformation.
observational model: Cohort
time perspective: Other
measure: Decrease of the deformation of more than 50% (measured in mm) after 6 months of treatment
time frame: After 6 months of treatment
description: Dynamic compression system
measure: Failure of treatment assessed by the patient, ie if the patients considers the treatment to have failed, if he choose to underwent surgery afterwards, or if he considered the pectus carinatum to have relapsed
time frame: After the end of treatment (6 months to 2 years)
description: Dynamic compression system
arm group label: Retrospective cohort
description: 340 to 400 patients
arm group label: Validation cohort
description: 120 patients
intervention type: Other
intervention name: dynamic compression system
description: It is a harness that the patient wears all day long for an average duration of 1 year, and that remodels the chest by exerting a moderate pressure on it
arm group label: Retrospective cohort
arm group label: Validation cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 40 Years
healthy volunteers: No
last name: Aurélien SCALABRE
role: Principal Investigator
affiliation: CHU Saint-Etienne
last name: Aurélien SCALABRE
phone: 04 77 82 94 49
email: aurelien.scalabre@chu-etienne.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Pectus Carinatum
sharing ipd: No