<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/NCT01691729</url>
  </required_header>
  <id_info>
    <org_study_id>A739</org_study_id>
    <nct_id>NCT01691729</nct_id>
  </id_info>
  <brief_title>Comparison Study of 3 Ostomy Products</brief_title>
  <official_title>A Randomized, Multicenter, Cross-Over Study Comparing the Performance of Three Ostomy Accessory Products</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ConvaTec Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ConvaTec Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To purpose of the study is to evaluate and compare the efficacy of three ostomy accessory&#xD;
      products.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study was to evaluate and compare the efficacy of three ostomy&#xD;
      accessory products in terms of leakage and wear time. Secondary objectives were to evaluate&#xD;
      and compare the safety of three ostomy accessory products, and to assess and compare the&#xD;
      performance of the three products in terms of use and overall impression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Leakage &amp; Wear Time</measure>
    <time_frame>10 days</time_frame>
    <description>Evaluation and comparison of the efficacy of three ostomy accessory products in terms of leakage and wear time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>10 days</time_frame>
    <description>Evaluation and comparison of the safety of three ostomy accessory products</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Ostomy</condition>
  <arm_group>
    <arm_group_label>Ostomy 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy AccessoryProduct/Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ostomy 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ostomy 3</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ostomy 4</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ostomy 5</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ostomy 6</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #1</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ostomy accessory</intervention_name>
    <description>Wearing each of the devices for 10 days each</description>
    <arm_group_label>Ostomy 1</arm_group_label>
    <arm_group_label>Ostomy 2</arm_group_label>
    <arm_group_label>Ostomy 3</arm_group_label>
    <arm_group_label>Ostomy 4</arm_group_label>
    <arm_group_label>Ostomy 5</arm_group_label>
    <arm_group_label>Ostomy 6</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has an ostomy&#xD;
&#xD;
          -  Is at least 18 years of age&#xD;
&#xD;
          -  Has a stoma for at least 3 months&#xD;
&#xD;
          -  Other than thier ostomy is considered to have a healthy/stable health&#xD;
&#xD;
          -  Is able to take care of their stoma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known sensitivity to any of the ostomy devices or components&#xD;
&#xD;
          -  Is undergoing chemotherapy or radiotherapy&#xD;
&#xD;
          -  Has participated in a clinical study within the past 30 days&#xD;
&#xD;
          -  Has a medical condition, in which in the opinion of the Investigator would not be a&#xD;
             good candidate for the study and justifies exclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kim Peters</last_name>
    <role>Study Director</role>
    <affiliation>ConvaTec Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Independent Nurse Consultants</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85742</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ET Nursing Services</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32257</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Image Specialties</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ID MED Inc.</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>December 5, 2022</last_update_submitted>
  <last_update_submitted_qc>December 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 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/NCT01691729
org study id: A739
nct id: NCT01691729
lead sponsor: 
has dmc: No
To purpose of the study is to evaluate and compare the efficacy of three ostomy accessory
      products.
The primary objective of this study was to evaluate and compare the efficacy of three ostomy
      accessory products in terms of leakage and wear time. Secondary objectives were to evaluate
      and compare the safety of three ostomy accessory products, and to assess and compare the
      performance of the three products in terms of use and overall impression.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Leakage & Wear Time
time frame: 10 days
description: Evaluation and comparison of the efficacy of three ostomy accessory products in terms of leakage and wear time.
measure: Number of adverse events
time frame: 10 days
description: Evaluation and comparison of the safety of three ostomy accessory products
arm group label: Ostomy 1
arm group type: Other
description: 3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy AccessoryProduct/Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2
arm group label: Ostomy 2
arm group type: Other
description: 3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1
arm group label: Ostomy 3
arm group type: Other
description: 3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product
arm group label: Ostomy 4
arm group type: Other
description: 3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product
arm group label: Ostomy 5
arm group type: Other
description: 3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2
arm group label: Ostomy 6
arm group type: Other
description: 3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #1
intervention type: Device
intervention name: Ostomy accessory
description: Wearing each of the devices for 10 days each
arm group label: Ostomy 1
arm group label: Ostomy 2
arm group label: Ostomy 3
arm group label: Ostomy 4
arm group label: Ostomy 5
arm group label: Ostomy 6
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kim Peters
role: Study Director
affiliation: ConvaTec Inc.
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor