<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/NCT03770078</url>
  </required_header>
  <id_info>
    <org_study_id>CP300</org_study_id>
    <nct_id>NCT03770078</nct_id>
  </id_info>
  <brief_title>Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma</brief_title>
  <official_title>Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coloplast A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coloplast A/S</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>
      The study investigates the performance of a new adhesive with regard to the skin condition&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 12, 2018</start_date>
  <completion_date type="Actual">March 6, 2019</completion_date>
  <primary_completion_date type="Actual">March 6, 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Trans Epidermal Water Loss</measure>
    <time_frame>Four weeks</time_frame>
    <description>Trans epidermal water loss is an objective skin measurement that is measures the evaporation of water on the skin surface using a probe (DermaLab).The trans epidermal water loss is a measure for the skins barrier function. There is always aloss of water from the skin due to evaporation. When the skin barrier is damaged this evaporation of water increases. Thus, transepidermal water loss can be used to assess skin damage</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Ileostomy - Stoma</condition>
  <condition>Colostomy Stoma</condition>
  <arm_group>
    <arm_group_label>Study period</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First the subjects will use the comparator (SenSura Mio) and then the test products (Test Product A)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Test Product A</intervention_name>
    <description>The test product is a newly developed ostomy product</description>
    <arm_group_label>Study period</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have given written informed consent&#xD;
&#xD;
          -  Have an ileostomy or a colostomy with liquid* output (as their usual output)&#xD;
&#xD;
          -  Be at least 18 years of age and have full legal capacity&#xD;
&#xD;
          -  Have had their stoma for at least three months&#xD;
&#xD;
          -  Be able to use products with max cut size 45 mm&#xD;
&#xD;
          -  Have self-reported problems with leakage** (three times within 14 days)&#xD;
&#xD;
          -  Handle the Clinical App, test product and comparator product themselves&#xD;
&#xD;
          -  Use a flat SenSura® Mio or a flat SenSura® with standard adhesive as their current&#xD;
             product&#xD;
&#xD;
          -  Minimum change of baseplate at least once every 3rd day&#xD;
&#xD;
          -  Are willing and suitable (determined by investigator/study nurse) to use the test&#xD;
             product and comparator without using a paste/mouldable ring during the investigation&#xD;
&#xD;
          -  Are willing and suitable (determined by investigator/study nurse) to use a 1-piece&#xD;
             product during the investigation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are currently receiving or have within the past two months received radio-and/or&#xD;
             chemotherapy (low doses chemotherapy are allowed for other indications than cancer,&#xD;
             e.g. below 15 mg methotrexate for rheumatoid arthritis)&#xD;
&#xD;
          -  Are currently receiving or have within the past month received topical steroid&#xD;
             treatment in the peristomal skin area (e.g. lotion or spray) or systemic treatment*&#xD;
             (e.g. injection or tablets).&#xD;
&#xD;
          -  Get a positive result of a pregnancy test for women of childbearing age/fertile&#xD;
             (**clarified in section 6.3.2)&#xD;
&#xD;
          -  Are breast feeding&#xD;
&#xD;
          -  Are participating in other interventional clinical investigations or have previously&#xD;
             participated in this investigation&#xD;
&#xD;
        Exception:&#xD;
&#xD;
        Participation in other Coloplast in-house clinical investigations is accepted under the&#xD;
        circumstances that the subject has paused the activities in the investigation and are&#xD;
        otherwise complying with the inclusion and exclusion criteria of this (CP300) protocol.&#xD;
&#xD;
        - Have known hypersensitivity towards any of the products used in the investigation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Birte P Jakobsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Consultant</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CCBR Aalborg</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coloplast</name>
      <address>
        <city>Humlebæk</city>
        <zip>3050</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCBR Vejle</name>
      <address>
        <city>Vejle</city>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KTA Prim Stockholm</name>
      <address>
        <city>Stockholm</city>
        <zip>11361</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Sweden</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>September 1, 2020</last_update_submitted>
  <last_update_submitted_qc>September 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 3, 2020</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/NCT03770078
org study id: CP300
nct id: NCT03770078
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study investigates the performance of a new adhesive with regard to the skin condition
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Trans Epidermal Water Loss
time frame: Four weeks
description: Trans epidermal water loss is an objective skin measurement that is measures the evaporation of water on the skin surface using a probe (DermaLab).The trans epidermal water loss is a measure for the skins barrier function. There is always aloss of water from the skin due to evaporation. When the skin barrier is damaged this evaporation of water increases. Thus, transepidermal water loss can be used to assess skin damage
arm group label: Study period
arm group type: Experimental
description: First the subjects will use the comparator (SenSura Mio) and then the test products (Test Product A)
intervention type: Device
intervention name: Test Product A
description: The test product is a newly developed ostomy product
arm group label: Study period
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Birte P Jakobsen, MD
role: Principal Investigator
affiliation: Consultant
facility: 
facility: 
facility: 
facility: 
country: Denmark
country: Sweden
responsible party type: Sponsor