<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/NCT02253186</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A01008-39</org_study_id>
    <nct_id>NCT02253186</nct_id>
  </id_info>
  <brief_title>Clinical Study to Assess Safety and Efficacy of a New Armsleeve in the Management of Arm Lymphoedema</brief_title>
  <acronym>MARILYN</acronym>
  <official_title>Monocentre, Controlled, Randomized, Open Label, Clinical Study to Assess Safety and Efficacy of Auto-Adjustable MOBIDERM(R) Arm Sleeve in the Management of Upper Limb Lymphoedema During Night-time of Maintenance Phase</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Thuasne</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Thuasne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to assess the effect of a new Armsleeve, worn during the night&#xD;
      during maintenance phase of upper limb lymphoedema treatment in combination with Day-time&#xD;
      usual lymphology hosiery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in excess arm volume</measure>
    <time_frame>between Day 0 and Day 30</time_frame>
    <description>Excess arm volume is defined as the volumetric difference between the affected upper limb compared to the contralateral upper limb, calculated with truncated cone formula</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Lymphedema</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients wear, for 90 days, the experimental Auto-Adjustable MOBIDERM® Armsleeve during night-time and a usual custom-made compressive armsleeve during Day-time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients wear, for 30 days, only a usual custom-made compressive armsleeve during Day-time and no garment during night-time. Then, for the next 60 days, patients wear the experimental Auto-Adjustable MOBIDERM® Armsleeve during night-time and a usual custom-made compressive armsleeve during Day-time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Auto-Adjustable MOBIDERM Armsleeve</intervention_name>
    <arm_group_label>Group I</arm_group_label>
    <other_name>MOBIDERM Autofit</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unilateral secondary upper limb lymphoedema of stage II or III, following breast&#xD;
             cancer&#xD;
&#xD;
          -  Patients hospitalized for an intensive phase of decongestive lymphoedema therapy (DLT)&#xD;
             for whom a decrease of lymphoedema volume has been achieved during hospitalization&#xD;
&#xD;
          -  Lymphoedema with evident pitting sign (assessed as ++ or +++)&#xD;
&#xD;
          -  Requiring compression therapy for, at least, the next 3 months.&#xD;
&#xD;
          -  Affected arm that fits with one of the 6 standard sizes of the Auto-Adjustable&#xD;
             MOBIDERM® armsleeve provided.&#xD;
&#xD;
          -  Signed informed consent prior to any study-mandated procedure.&#xD;
&#xD;
          -  Not under any administrative or legal supervision.&#xD;
&#xD;
          -  Covered by a health insurance system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stage I lymphoedema&#xD;
&#xD;
          -  Active cellulitis&#xD;
&#xD;
          -  Lymphoedema associated with active cancer needing acute chemotherapy&#xD;
&#xD;
          -  Motor and sensitive neurological deficiency&#xD;
&#xD;
          -  Post-operative oedema (i.e acute oedema following breast cancer-related surgery)&#xD;
&#xD;
          -  Patient participating in any other clinical study&#xD;
&#xD;
          -  Unlikely to be followed up to 3 months with clinical assessment&#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>Isabelle Quere, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires</name>
      <address>
        <city>Montpellier Cedex 5</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>December 4, 2015</last_update_submitted>
  <last_update_submitted_qc>December 4, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2015</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>Lymphedema</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/NCT02253186
org study id: 2014-A01008-39
nct id: NCT02253186
lead sponsor: 
has dmc: No
The objective of the study is to assess the effect of a new Armsleeve, worn during the night
      during maintenance phase of upper limb lymphoedema treatment in combination with Day-time
      usual lymphology hosiery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in excess arm volume
time frame: between Day 0 and Day 30
description: Excess arm volume is defined as the volumetric difference between the affected upper limb compared to the contralateral upper limb, calculated with truncated cone formula
arm group label: Group I
arm group type: Experimental
description: Patients wear, for 90 days, the experimental Auto-Adjustable MOBIDERM® Armsleeve during night-time and a usual custom-made compressive armsleeve during Day-time.
arm group label: Group II
arm group type: No Intervention
description: Patients wear, for 30 days, only a usual custom-made compressive armsleeve during Day-time and no garment during night-time. Then, for the next 60 days, patients wear the experimental Auto-Adjustable MOBIDERM® Armsleeve during night-time and a usual custom-made compressive armsleeve during Day-time.
intervention type: Device
intervention name: Auto-Adjustable MOBIDERM Armsleeve
arm group label: Group I
other name: MOBIDERM Autofit
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Isabelle Quere, Prof
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Lymphedema