<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/NCT03784989</url>
  </required_header>
  <id_info>
    <org_study_id>CP281</org_study_id>
    <nct_id>NCT03784989</nct_id>
  </id_info>
  <brief_title>Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Kids Device</brief_title>
  <official_title>A Multi-Centre Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Kids Device in Subjects With a Stoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coloplast A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's National</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Driscoll Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>IWK Health Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      This is a post market clinical follow-up study and devices will carry the CE mark once the&#xD;
      study is initiated.&#xD;
&#xD;
      The investigational device is SenSura® Mio Kids, which is a flat ostomy device. The device is&#xD;
      comprised by a baseplate connected to a bag. The coupling between baseplate and bag can be&#xD;
      either welded together, referred to as a 1-piece (1P) system, or assembled as separate parts,&#xD;
      referred to as a 2-piece (2P) system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research is to gather more information about how well the SenSura® Mio&#xD;
      Kids ostomy device works, and how safe it is. This device has already been studied and&#xD;
      approved to be used in the United States. It has a European CE-mark, which means it has met&#xD;
      European health and safety requirements. SenSura® Mio Kids is a flat ostomy device that is&#xD;
      made to be used for kids from 6 months up to 4 years of age.&#xD;
&#xD;
      The reason for this study is to find out how well the new SenSura® Mio Kids device works&#xD;
      compared to the standard of care device. We can learn about this by asking people who have&#xD;
      used it about how well it worked and how comfortable it was.&#xD;
&#xD;
      The Investigator/study nurse will decide whether the subject would benefit from switching to&#xD;
      SenSura® Mio Kids and if so, the subject will be invited to take part in the study. The study&#xD;
      design is observational. That means that the ostomy device, and the skin around the stoma,&#xD;
      will be observed while receiving the stoma care they normally would. This study design will&#xD;
      help the researchers see how well the device works when it is used in the usual way, and&#xD;
      makes it easier for the people who are participating in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">April 15, 2019</start_date>
  <completion_date type="Actual">September 8, 2020</completion_date>
  <primary_completion_date type="Actual">September 8, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Median wear time</measure>
    <time_frame>2-3 weeks</time_frame>
    <description>of 8 baseplate changes</description>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Stoma Ileostomy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The population in this study are subjects from the age of 6 months (calculated from term&#xD;
        age meaning 40 gestational weeks) to 4 years either with a colo-, ileo- or urostomy or a&#xD;
        loop stoma, or two stomas placed closely together. Subjects can participate in the PMCF&#xD;
        study if they fulfill the in-/exclusion criteria as listed in the tables below. However,&#xD;
        the per protocol population only include 30 subjects as needed for the compara-tive&#xD;
        performance evaluation (Group 1), and these subjects must fulfill inclusion criteria no. 3&#xD;
        (subjects should use a competitor device).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have a colostomy, ileostomy, urostomy, loop stoma, or two stomas placed closely&#xD;
             together&#xD;
&#xD;
          2. Have given written informed consent (the legal authorized representative of the&#xD;
             subject)&#xD;
&#xD;
          3. Group 1 subjects should use a competitor device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin&#xD;
        (as-sessed by the investigator)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>4 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Driscoll Childrens Hospital</name>
      <address>
        <city>Corpus Christi</city>
        <state>Texas</state>
        <zip>78411</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>November 15, 2022</last_update_submitted>
  <last_update_submitted_qc>November 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2022</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/NCT03784989
org study id: CP281
nct id: NCT03784989
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a post market clinical follow-up study and devices will carry the CE mark once the
      study is initiated.

      The investigational device is SenSura® Mio Kids, which is a flat ostomy device. The device is
      comprised by a baseplate connected to a bag. The coupling between baseplate and bag can be
      either welded together, referred to as a 1-piece (1P) system, or assembled as separate parts,
      referred to as a 2-piece (2P) system.
The purpose of this research is to gather more information about how well the SenSura® Mio
      Kids ostomy device works, and how safe it is. This device has already been studied and
      approved to be used in the United States. It has a European CE-mark, which means it has met
      European health and safety requirements. SenSura® Mio Kids is a flat ostomy device that is
      made to be used for kids from 6 months up to 4 years of age.

      The reason for this study is to find out how well the new SenSura® Mio Kids device works
      compared to the standard of care device. We can learn about this by asking people who have
      used it about how well it worked and how comfortable it was.

      The Investigator/study nurse will decide whether the subject would benefit from switching to
      SenSura® Mio Kids and if so, the subject will be invited to take part in the study. The study
      design is observational. That means that the ostomy device, and the skin around the stoma,
      will be observed while receiving the stoma care they normally would. This study design will
      help the researchers see how well the device works when it is used in the usual way, and
      makes it easier for the people who are participating in the study.
observational model: Other
time perspective: Retrospective
measure: Median wear time
time frame: 2-3 weeks
description: of 8 baseplate changes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: 4 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor