<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/NCT01698827</url>
  </required_header>
  <id_info>
    <org_study_id>Gastrotubes5A</org_study_id>
    <nct_id>NCT01698827</nct_id>
  </id_info>
  <brief_title>Replacement Gastrostomy Tubes: Technical and Clinical Comparison of Five Commercial Models</brief_title>
  <official_title>Replacement Gastrostomy Tubes: Technical and Clinical Comparison of Five Commercial Models</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in&#xD;
      the market, however durability is variable. In a prospective randomized study, five&#xD;
      commercial devices available in the market will be tested in 20 consecutive patients each.&#xD;
      Tube performance will be observed during 6 months and durability will be assessed by&#xD;
      Kaplan-Meier curves as well as Cox regression analysis.It is hypothesized that tube design&#xD;
      and material will influence outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in&#xD;
      the market, however durability is variable. In a prospective randomized study, five&#xD;
      commercial devices available in the market will be tested in 20 consecutive patients each,in&#xD;
      patients submitted to long-term outpatient nutritional support. Tube performance will be&#xD;
      observed during 6 months and durability will be assessed by Kaplan-Meier curves as well as&#xD;
      Cox regression analysis.It is hypothesized that tube design and material will influence&#xD;
      outcome.This study is important because tube dysfunction and unscheduled changes are&#xD;
      expensive troubles that disrupt the nutritional protocol and are responsible for multiple&#xD;
      inconveniences to the patient and the caretaker.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Tube durability</measure>
    <time_frame>6 months</time_frame>
    <description>Durability of the tube will be calculated as days in use till need for replacement, within the time frame of 6 months of observation. 180 days of continuous use will correspond to 100% durability, and 18 days of use as 10% durability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tube rupture</measure>
    <time_frame>6 months</time_frame>
    <description>Causes for replacement within the 6 months will be documented, with emphasis on tube or ballooon rupture</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of previous tube changes</measure>
    <time_frame>6 months</time_frame>
    <description>Tube outcome will be analyzed in the light of number of previous tube changes in the patients (first tube/no previous change vs. patients on long-term treatment with multiple tube changes)</description>
  </other_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Gastrostomy Tube Rupture</condition>
  <condition>Gastrostomy Tube Durability</condition>
  <condition>Gastrostomy Tube Convenience</condition>
  <arm_group>
    <arm_group_label>Kangaroo</arm_group_label>
    <description>20 patients managed by &quot;Kangaroo&quot; gastrostomy tubes. Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cook</arm_group_label>
    <description>20 patients receiving &quot;Wilson Cook&quot; gastrostomy tubes.Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Silmag</arm_group_label>
    <description>20 patients managed by &quot;Silmag&quot; gastrostomy tubes.Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Freka</arm_group_label>
    <description>20 patients carrying &quot;Freka&quot; gastrostomy tubes.Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bard</arm_group_label>
    <description>20 patients using the &quot;Bard&quot; gastrostomy tube. Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tube assessment visits</intervention_name>
    <description>Patients will return every 2 months for clinical questionnaire about leaks, obstructions or other dysfunctions of the tube. Objective tube examination for cracks, rupture, obstruction or dislodgement, along with replacement if necessary, will be carried out (total of 3 visits/6 months)</description>
    <arm_group_label>Bard</arm_group_label>
    <arm_group_label>Cook</arm_group_label>
    <arm_group_label>Freka</arm_group_label>
    <arm_group_label>Kangaroo</arm_group_label>
    <arm_group_label>Silmag</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults on long-term nutritional care requiring prolonged gastrostomy feeding via&#xD;
        percutaneous endoscopic gastrostomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults undergoing long-term home enteral nutrition via percutaneous endoscopic&#xD;
             gastrostomy due to neurologic conditions or dysphagia.&#xD;
&#xD;
          -  registered at the outpatient endoscopy service&#xD;
&#xD;
          -  clinical stable and with the possibility of returning for scheduled visits&#xD;
&#xD;
          -  expected duration of enteral feeding &gt; 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sepsis,&#xD;
&#xD;
          -  shock,&#xD;
&#xD;
          -  coma,&#xD;
&#xD;
          -  other types of digestive access (surgical gastrostomy, jejunostomy)&#xD;
&#xD;
          -  terminal disease,&#xD;
&#xD;
          -  lack of cooperation,&#xD;
&#xD;
          -  refusal to participate in the protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joel Faintuch, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital das Clinicas, Sao Paulo, Brazil</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paulo Sakai, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital das Clinicas, Sao Paulo, Brazil</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emanuele L Villela, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital das Clinicas, Sao Paulo, Brazil</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital das Clinicas- Central Institute ICHC- 9th Floor Rm 9077</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clinicas</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Campoli P, Cardoso D, Turchi M, Mota O. Clinical trial: a randomized study comparing the durability of silicone and latex percutaneous endoscopic gastrostomy tubes. Dig Endosc. 2011 Apr;23(2):135-9. doi: 10.1111/j.1443-1661.2010.01051.x. Epub 2010 Dec 7.</citation>
    <PMID>21429018</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 22, 2012</study_first_submitted>
  <study_first_submitted_qc>September 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>September 29, 2012</last_update_submitted>
  <last_update_submitted_qc>September 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Joel Faintuch</investigator_full_name>
    <investigator_title>Associate Professor, Department of Gastroenterology</investigator_title>
  </responsible_party>
  <keyword>gastrostomy</keyword>
  <keyword>tube</keyword>
  <keyword>endoscopic</keyword>
  <keyword>replacement</keyword>
  <keyword>tube rupture</keyword>
  <keyword>durability</keyword>
  <keyword>tube loss</keyword>
  <keyword>balloon rupture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <!-- 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/NCT01698827
org study id: Gastrotubes5A
nct id: NCT01698827
lead sponsor: 
has dmc: No
Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in
      the market, however durability is variable. In a prospective randomized study, five
      commercial devices available in the market will be tested in 20 consecutive patients each.
      Tube performance will be observed during 6 months and durability will be assessed by
      Kaplan-Meier curves as well as Cox regression analysis.It is hypothesized that tube design
      and material will influence outcome.
Multiple models of replacement tubes for percutaneous endoscopic gastrostomy are available in
      the market, however durability is variable. In a prospective randomized study, five
      commercial devices available in the market will be tested in 20 consecutive patients each,in
      patients submitted to long-term outpatient nutritional support. Tube performance will be
      observed during 6 months and durability will be assessed by Kaplan-Meier curves as well as
      Cox regression analysis.It is hypothesized that tube design and material will influence
      outcome.This study is important because tube dysfunction and unscheduled changes are
      expensive troubles that disrupt the nutritional protocol and are responsible for multiple
      inconveniences to the patient and the caretaker.
observational model: Cohort
time perspective: Prospective
measure: Tube durability
time frame: 6 months
description: Durability of the tube will be calculated as days in use till need for replacement, within the time frame of 6 months of observation. 180 days of continuous use will correspond to 100% durability, and 18 days of use as 10% durability.
measure: Tube rupture
time frame: 6 months
description: Causes for replacement within the 6 months will be documented, with emphasis on tube or ballooon rupture
measure: Number of previous tube changes
time frame: 6 months
description: Tube outcome will be analyzed in the light of number of previous tube changes in the patients (first tube/no previous change vs. patients on long-term treatment with multiple tube changes)
arm group label: Kangaroo
description: 20 patients managed by "Kangaroo" gastrostomy tubes. Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.
arm group label: Cook
description: 20 patients receiving "Wilson Cook" gastrostomy tubes.Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.
arm group label: Silmag
description: 20 patients managed by "Silmag" gastrostomy tubes.Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.
arm group label: Freka
description: 20 patients carrying "Freka" gastrostomy tubes.Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.
arm group label: Bard
description: 20 patients using the "Bard" gastrostomy tube. Patients will be submitted to initial screening and tube replacement, followed tube assessment visits every two months, till 6 months.
intervention type: Other
intervention name: Tube assessment visits
description: Patients will return every 2 months for clinical questionnaire about leaks, obstructions or other dysfunctions of the tube. Objective tube examination for cracks, rupture, obstruction or dislodgement, along with replacement if necessary, will be carried out (total of 3 visits/6 months)
arm group label: Bard
arm group label: Cook
arm group label: Freka
arm group label: Kangaroo
arm group label: Silmag
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Joel Faintuch, MD, PhD
role: Study Chair
affiliation: Hospital das Clinicas, Sao Paulo, Brazil
last name: Paulo Sakai, MD, PhD
role: Study Director
affiliation: Hospital das Clinicas, Sao Paulo, Brazil
last name: Emanuele L Villela, MD
role: Principal Investigator
affiliation: Hospital das Clinicas, Sao Paulo, Brazil
facility: 
facility: 
country: Brazil
citation: Campoli P, Cardoso D, Turchi M, Mota O. Clinical trial: a randomized study comparing the durability of silicone and latex percutaneous endoscopic gastrostomy tubes. Dig Endosc. 2011 Apr;23(2):135-9. doi: 10.1111/j.1443-1661.2010.01051.x. Epub 2010 Dec 7.
PMID: 21429018
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Joel Faintuch
investigator title: Associate Professor, Department of Gastroenterology
mesh term: Rupture