<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/NCT02223104</url>
  </required_header>
  <id_info>
    <org_study_id>OPM-G-H-1301</org_study_id>
    <nct_id>NCT02223104</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Multicenter Study to Evaluate the Performance of Flexima® Active vs. Sensura® in Patients With Colostomy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>BBraun Medical SAS</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BBraun Medical SAS</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate that the performance of Flexima Active is&#xD;
      non-inferior to the performance of Sensura.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Level of leakage under the skin protector of Flexima Active in comparison with level of leakage under the skin protector of Sensura.</measure>
    <time_frame>Up to one day for closed pouches and up to two days for drainable pouches.</time_frame>
    <description>The patient will evaluate the level of leakage under the skin protector after each removal of pouch.&#xD;
A 4 scale level will be used:&#xD;
&quot;no leakage under the skin protector&quot;,&#xD;
&quot;leakage under the skin protector not soiling clothes&quot;,&#xD;
&quot;leakage under the skin protector soiling clothes&quot;,&#xD;
&quot;sudden and massive leakage under the skin protector&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of the condition of peristomal skin</measure>
    <time_frame>At V1 and V2 protocol visits (at day 0 and day 14)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of each pouch</measure>
    <time_frame>At each protocol visit (day 0, day 14 and day 28)</time_frame>
    <description>Acceptability is defined by those criteria:&#xD;
Wearing comfort, Flexibility, Conformability (skin protector adaptation to the skin relief), Ease of handling (pouch application and pouch removal), Tack (immediate adhesivity to the skin after application), Adhesivity (during wear time), Residues on the skin after pouch removal, Filter performance (odours neutralization, limitation of ballooning of the bag), Security feeling with skin protector, Overall security feeling, Overall satisfaction with skin protector, Overall satisfaction with the appliance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preference between Flexima® Active and Sensura®</measure>
    <time_frame>At each protocol visits (at day 0, day 14 and day 28)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the quality of life with Stoma-QoL questionnaire</measure>
    <time_frame>At each protocol visits (at day 0, day 14 and day 28)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse(s) Event(s)</measure>
    <time_frame>At each protocol visits (at day 0, day 14 and day 28)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Colostomy</condition>
  <arm_group>
    <arm_group_label>Sensura</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ostomy pouch</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Flexima Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ostomy pouch</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Flexima Active</intervention_name>
    <arm_group_label>Sensura</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sensura</intervention_name>
    <arm_group_label>Flexima Active</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient is at least 18 years old&#xD;
&#xD;
          -  patient having a colostomy with a diameter less than 50 mm for users of midi pouches&#xD;
             or having a colostomy with a diameter less than 65 mm for users of maxi pouches&#xD;
&#xD;
          -  patient having a colostomy for at least 1 month&#xD;
&#xD;
          -  patient using currently a one-piece flat ostomy appliance with closed or drainable&#xD;
             bags&#xD;
&#xD;
          -  patient using minimum 1 product per day with closed pouches or minimum 1 product every&#xD;
             two days with drainable pouches&#xD;
&#xD;
          -  patient capable to apply and remove the pouch himself or with the help of a caregiver&#xD;
             (except health care professional)&#xD;
&#xD;
          -  patient having a mental capacity to participate to the study (i.e. to understand the&#xD;
             study and to answer to the questions)&#xD;
&#xD;
          -  patient agrees to test Flexima® Active (size midi or maxi, beige) during 14 days and&#xD;
             Sensura® (size midi or maxi, beige) during 14 days&#xD;
&#xD;
          -  patient covered by social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient receiving or having received, within the last month, chemotherapy or&#xD;
             radiotherapy&#xD;
&#xD;
          -  patient currently suffering from peristomal skin complications (bleeding or red and&#xD;
             broken skin at the time of inclusion)&#xD;
&#xD;
          -  patient currently receiving or having received within the past three weeks systemic or&#xD;
             local steroid medication in the peristomal skin&#xD;
&#xD;
          -  patient already participating in another clinical study or who have previously&#xD;
             participated in this investigation&#xD;
&#xD;
          -  pregnant or breast-feeding woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bichat Hospital</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>October 25, 2013</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>July 30, 2015</last_update_submitted>
  <last_update_submitted_qc>July 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02223104
org study id: OPM-G-H-1301
nct id: NCT02223104
lead sponsor: 
has dmc: No
The purpose of this study is to demonstrate that the performance of Flexima Active is
      non-inferior to the performance of Sensura.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Level of leakage under the skin protector of Flexima Active in comparison with level of leakage under the skin protector of Sensura.
time frame: Up to one day for closed pouches and up to two days for drainable pouches.
description: The patient will evaluate the level of leakage under the skin protector after each removal of pouch.
A 4 scale level will be used:
"no leakage under the skin protector",
"leakage under the skin protector not soiling clothes",
"leakage under the skin protector soiling clothes",
"sudden and massive leakage under the skin protector".
measure: Assessment of the condition of peristomal skin
time frame: At V1 and V2 protocol visits (at day 0 and day 14)
measure: Acceptability of each pouch
time frame: At each protocol visit (day 0, day 14 and day 28)
description: Acceptability is defined by those criteria:
Wearing comfort, Flexibility, Conformability (skin protector adaptation to the skin relief), Ease of handling (pouch application and pouch removal), Tack (immediate adhesivity to the skin after application), Adhesivity (during wear time), Residues on the skin after pouch removal, Filter performance (odours neutralization, limitation of ballooning of the bag), Security feeling with skin protector, Overall security feeling, Overall satisfaction with skin protector, Overall satisfaction with the appliance
measure: Preference between Flexima® Active and Sensura®
time frame: At each protocol visits (at day 0, day 14 and day 28)
measure: Assessment of the quality of life with Stoma-QoL questionnaire
time frame: At each protocol visits (at day 0, day 14 and day 28)
measure: Adverse(s) Event(s)
time frame: At each protocol visits (at day 0, day 14 and day 28)
arm group label: Sensura
arm group type: Active Comparator
description: Ostomy pouch
arm group label: Flexima Active
arm group type: Experimental
description: Ostomy pouch
intervention type: Device
intervention name: Flexima Active
arm group label: Sensura
intervention type: Device
intervention name: Sensura
arm group label: Flexima Active
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor