<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/NCT02208258</url>
  </required_header>
  <id_info>
    <org_study_id>CON/2013/FI003</org_study_id>
    <nct_id>NCT02208258</nct_id>
  </id_info>
  <brief_title>Efficacy, Safety, and Performance Study of a Novel Device Designed to Manage Fecal Incontinence in Hospitalized Bedridden Patients With Liquid to Semi-formed Stool.</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Consure Medical Pvt. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Consure Medical Pvt. Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety, efficacy, and functionality of the&#xD;
      Consure 120 Stool Management System in hospitalized bedridden patients suffering from fecal&#xD;
      incontinence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Hospital had initiated a conflicting study, hence the study was terminated.&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Visual confirmation that fecal material is diverted into the external collection bag through the device.</measure>
    <time_frame>120 +/- 8 hours</time_frame>
    <description>Yes or No response to visual observation of stool being collected through the transit sheath and collection bag.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual confirmation of no soiling, leaking or seepage of fecal secretions from the periphery of the device.</measure>
    <time_frame>120 +/- 8 hours</time_frame>
    <description>Yes or No response to visual observation of soiling, leaking or seepage around periphery of device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of hours for which the device stays on without change or removal.</measure>
    <time_frame>120 +/- 8 hours</time_frame>
    <description>Quantitative measure of duration of device use. The cause of the change or removal will be documented.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual confirmation of no active bleeding on the external periphery of the device (transit sheath or collection bag) over the usage of the device.</measure>
    <time_frame>120 +/- 8 hours</time_frame>
    <description>Yes or No response from visual observation of any bleeding on the external periphery of the device.</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Fecal Incontinence</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Consure 120 Stool Management System</intervention_name>
    <description>Novel device designed to manage fecal incontinence in hospitalized bedridden patients with liquid to semi-formed stool.</description>
    <other_name>Consure 120 SMS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients, more than 18 years of age incontinent with liquid to&#xD;
             semi-formed stool.&#xD;
&#xD;
          -  Non-ambulatory, hospitalized patients.&#xD;
&#xD;
          -  History of passage of at least 1 stool in 24 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with suspected or confirmed rectal mucosal impairment or pathology.&#xD;
&#xD;
          -  Patients with have undergone descending colon or rectal surgery within the preceding&#xD;
             six months.&#xD;
&#xD;
          -  Patients with significant hemorrhoids, growth, fissure, stricture, stenosis or local&#xD;
             pathology (either benign and malignant) as observed during rectal examination.&#xD;
&#xD;
          -  Patients suspected to have impacted stool or is suffering from constipation.&#xD;
&#xD;
          -  Patients with confirmed pregnancy or suspected to be pregnant.&#xD;
&#xD;
          -  Patients that have planned MRI examination over the duration of the study.&#xD;
&#xD;
          -  Patients who have suffered recent cardiac arrest within the preceding 3 months.&#xD;
&#xD;
          -  Patients enrolled in another clinical study or clinical trial.&#xD;
&#xD;
          -  Patients on oral or IV anti-coagulation (e.g., IV heparin drip, acetylsalicylic acid ,&#xD;
             Plavix). Subcutaneous heparin or low molecular weight heparin are acceptable).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sharp HealthCare</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>January 28, 2016</last_update_submitted>
  <last_update_submitted_qc>January 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fecal incontinence, consure medical, semi formed stool, stool management system</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fecal Incontinence</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/NCT02208258
org study id: CON/2013/FI003
nct id: NCT02208258
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety, efficacy, and functionality of the
      Consure 120 Stool Management System in hospitalized bedridden patients suffering from fecal
      incontinence.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Visual confirmation that fecal material is diverted into the external collection bag through the device.
time frame: 120 +/- 8 hours
description: Yes or No response to visual observation of stool being collected through the transit sheath and collection bag.
measure: Visual confirmation of no soiling, leaking or seepage of fecal secretions from the periphery of the device.
time frame: 120 +/- 8 hours
description: Yes or No response to visual observation of soiling, leaking or seepage around periphery of device.
measure: Number of hours for which the device stays on without change or removal.
time frame: 120 +/- 8 hours
description: Quantitative measure of duration of device use. The cause of the change or removal will be documented.
measure: Visual confirmation of no active bleeding on the external periphery of the device (transit sheath or collection bag) over the usage of the device.
time frame: 120 +/- 8 hours
description: Yes or No response from visual observation of any bleeding on the external periphery of the device.
intervention type: Device
intervention name: Consure 120 Stool Management System
description: Novel device designed to manage fecal incontinence in hospitalized bedridden patients with liquid to semi-formed stool.
other name: Consure 120 SMS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fecal Incontinence