<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/NCT03041649</url>
  </required_header>
  <id_info>
    <org_study_id>16070489</org_study_id>
    <nct_id>NCT03041649</nct_id>
  </id_info>
  <brief_title>Mic-Key Versus Mini One Family Preference Comparison</brief_title>
  <acronym>MicKeyVMini</acronym>
  <official_title>Mic-Key Versus Mini: A Prospective, Randomized Trial for Family Preference Comparing Low Profile Balloon Gastrostomy Buttons</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Mercy Hospital Kansas City</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Mercy Hospital Kansas City</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to compare two low profile balloon gastrostomy button enteral&#xD;
      feeding devices, both currently used as standard of medical care. The investigators aim to&#xD;
      compare family preference and rate of complications between the two devices in a prospective&#xD;
      cohort of children. This is the first step in comparing initial and long-term outcomes along&#xD;
      with the need for seeking medical advice for gastrostomy site-related complications.&#xD;
&#xD;
      The secondary aim of this study is to follow this population long term (4 years) to document&#xD;
      the prevalence of: granulation tissue, infection, skin breakdown, and how long the&#xD;
      gastrostomy tube balloon remains functional (does not lose water).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center prospective, randomized study with a crossover design, comparing two&#xD;
      low profile balloon gastrostomy buttons (Figure 1), MIC-Key™ and MINI One™ that are routinely&#xD;
      used at CMH. Each subject will be randomly assigned to one button type at the time of initial&#xD;
      placement. After placement, standard practice is to perform the first gastrostomy change in&#xD;
      the clinic at 2 months where the primary caregivers replace the button under supervision.&#xD;
      Therefore, the initial device after randomization will remain in place for 2 months. At the&#xD;
      first scheduled device change, the other type of button will replace the original gastrostomy&#xD;
      button device. This will remain in place for another 2 months. At the routine visit at 4&#xD;
      months the parents will be asked to choose which button they prefer to keep. This will meet&#xD;
      the primary outcome endpoint of the study. The investigators will continue to follow as many&#xD;
      subjects as possible to 4 years in order to identify any potential differences in secondary&#xD;
      end points.&#xD;
&#xD;
      A caregiver satisfaction survey is routinely used in the clinics. Parent responses to this&#xD;
      survey will be also be used in the study analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">April 2020</completion_date>
  <primary_completion_date type="Actual">April 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Parent preference</measure>
    <time_frame>4 months</time_frame>
    <description>Parents will be asked which button they prefer to keep at the 4-month visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Enteral Access Assessment Sheet</measure>
    <time_frame>Up to 4 years after button placement</time_frame>
    <description>Providers will complete a brief checklist of gastrostomy tube maintenance and site complications at the 2-month button change, 4-month visit, and all subsequent follow-up visits while the button while the G-tube remains in place.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">158</enrollment>
  <condition>Gastroesophageal Reflux</condition>
  <condition>Feeding Disorder</condition>
  <condition>Family Satisfaction</condition>
  <arm_group>
    <arm_group_label>GT button change - Mic-Key</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to the Mic-Key arm will have the Mic-Key button placed initially at surgery, and at the first gastrostomy change in the clinic at 2 months, will change to the Mini One button. At the routine 4-month visit, parents will be asked which button they prefer to keep.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GT button change - Mini One</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to the Mini One arm will have the Mini One button placed initially at surgery, and at the first gastrostomy change in the clinic at 2 months, will change to the Mic-Key button. At the routine 4-month visit, parents will be asked which button they prefer to keep.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GT button change - Mic-Key</intervention_name>
    <description>After 2 months with each button, parents will be asked which button they prefer at the 4-month post-operational follow-up visit.</description>
    <arm_group_label>GT button change - Mini One</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GT button change - Mini One</intervention_name>
    <description>After 2 months with each button, parents will be asked which button they prefer at the 4-month post-operational follow-up visit.</description>
    <arm_group_label>GT button change - Mic-Key</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children ages 0-5 years of age requiring 0.8 cm or 1.0 cm gastrostomy feeding devices&#xD;
             for enteral nutrition seen in the Surgery, GI or Special Care clinics&#xD;
&#xD;
          -  Gastrostomy placement after IRB approval (enrollment will continue until 170 evaluable&#xD;
             subjects have completed the 4 month visit. Expected attrition for the 4 year follow-up&#xD;
             is 40%.&#xD;
&#xD;
          -  English-speaking families&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with dermatologic conditions influencing gastrostomy site healing and tract&#xD;
             epithelialization&#xD;
&#xD;
          -  Children with immunosuppression&#xD;
&#xD;
          -  Children with active malignancy requiring treatment&#xD;
&#xD;
          -  Inability to commit to 4 months follow up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shawn D St. Peter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Mercy Hospital Kansas City</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Mercy Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>October 19, 2021</last_update_submitted>
  <last_update_submitted_qc>October 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastroesophageal Reflux</keyword>
  <keyword>Feeding Disorder</keyword>
  <keyword>Gastrostomy tube</keyword>
  <keyword>Family Satisfaction</keyword>
  <keyword>GT button</keyword>
  <keyword>Enteral nutrition</keyword>
  <keyword>Gastrostomy button</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Feeding and Eating Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03041649
org study id: 16070489
nct id: NCT03041649
lead sponsor: 
has dmc: No
The objective of this study is to compare two low profile balloon gastrostomy button enteral
      feeding devices, both currently used as standard of medical care. The investigators aim to
      compare family preference and rate of complications between the two devices in a prospective
      cohort of children. This is the first step in comparing initial and long-term outcomes along
      with the need for seeking medical advice for gastrostomy site-related complications.

      The secondary aim of this study is to follow this population long term (4 years) to document
      the prevalence of: granulation tissue, infection, skin breakdown, and how long the
      gastrostomy tube balloon remains functional (does not lose water).
This is a single center prospective, randomized study with a crossover design, comparing two
      low profile balloon gastrostomy buttons (Figure 1), MIC-Key™ and MINI One™ that are routinely
      used at CMH. Each subject will be randomly assigned to one button type at the time of initial
      placement. After placement, standard practice is to perform the first gastrostomy change in
      the clinic at 2 months where the primary caregivers replace the button under supervision.
      Therefore, the initial device after randomization will remain in place for 2 months. At the
      first scheduled device change, the other type of button will replace the original gastrostomy
      button device. This will remain in place for another 2 months. At the routine visit at 4
      months the parents will be asked to choose which button they prefer to keep. This will meet
      the primary outcome endpoint of the study. The investigators will continue to follow as many
      subjects as possible to 4 years in order to identify any potential differences in secondary
      end points.

      A caregiver satisfaction survey is routinely used in the clinics. Parent responses to this
      survey will be also be used in the study analysis.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Parent preference
time frame: 4 months
description: Parents will be asked which button they prefer to keep at the 4-month visit.
measure: Enteral Access Assessment Sheet
time frame: Up to 4 years after button placement
description: Providers will complete a brief checklist of gastrostomy tube maintenance and site complications at the 2-month button change, 4-month visit, and all subsequent follow-up visits while the button while the G-tube remains in place.
arm group label: GT button change - Mic-Key
arm group type: Active Comparator
description: Subjects randomized to the Mic-Key arm will have the Mic-Key button placed initially at surgery, and at the first gastrostomy change in the clinic at 2 months, will change to the Mini One button. At the routine 4-month visit, parents will be asked which button they prefer to keep.
arm group label: GT button change - Mini One
arm group type: Active Comparator
description: Subjects randomized to the Mini One arm will have the Mini One button placed initially at surgery, and at the first gastrostomy change in the clinic at 2 months, will change to the Mic-Key button. At the routine 4-month visit, parents will be asked which button they prefer to keep.
intervention type: Other
intervention name: GT button change - Mic-Key
description: After 2 months with each button, parents will be asked which button they prefer at the 4-month post-operational follow-up visit.
arm group label: GT button change - Mini One
intervention type: Other
intervention name: GT button change - Mini One
description: After 2 months with each button, parents will be asked which button they prefer at the 4-month post-operational follow-up visit.
arm group label: GT button change - Mic-Key
criteria: 
gender: All
minimum age: 1 Day
maximum age: 5 Years
healthy volunteers: No
last name: Shawn D St. Peter, MD
role: Principal Investigator
affiliation: Children's Mercy Hospital Kansas City
facility: 
country: United States
responsible party type: Sponsor
mesh term: Gastroesophageal Reflux
mesh term: Feeding and Eating Disorders
sharing ipd: No