<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/NCT03790826</url>
  </required_header>
  <id_info>
    <org_study_id>CIFCAT-001</org_study_id>
    <nct_id>NCT03790826</nct_id>
  </id_info>
  <brief_title>Chronic Indwelling Foley and Catheter Associated Trauma (CIF-CAT) Study</brief_title>
  <official_title>Chronic Indwelling Foley and Catheter Associated Trauma (CIF-CAT) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nellie Medical, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nellie Medical, LLC</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine whether an indwelling low profile Kohli Atraumatic Catheter causes less&#xD;
      macro-morphologic inflammation and edema to the bladder mucosa than a traditional indwelling&#xD;
      Foley catheter as assess by computerized image analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Kohli Atraumatic Catheter similarly aims to reduce bladder mucosal trauma with its low&#xD;
      profile pancake shaped balloon versus the ovoid balloon of a traditional Foley catheter. The&#xD;
      Kohli Atraumatic Catheter has a short, opened-ended tip that minimally protrudes through a&#xD;
      patented low-profile donut-shaped balloon. The combination of the low profile and reduced tip&#xD;
      length prevents the catheter from contacting the bladder walls and thereby minimize&#xD;
      disruption of the bladder surface mucus layer and trauma to the urothelium - theoretically&#xD;
      reducing the chance of bacterial invasion. A trial in which sheep were randomized to a&#xD;
      traditional indwelling Foley catheter or a prototype Kohli Atraumatic Catheter demonstrated a&#xD;
      dramatic reduction in both bladder wall trauma and edema. The ulcerated area dropped from&#xD;
      7.2% to 1.8% (75%) and the edema from 26.9% to 13.0% (52%).&#xD;
&#xD;
      Statistical Analysis To compare the effects of 2 catheter types, data will be analyzed using&#xD;
      the general linear models tools from SAS/STAT software and presented as means ± standard&#xD;
      error of the mean. The model will include 2 catheter types, inflamed vs non-inflamed areas,&#xD;
      and their interactions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 2019</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bladder mucosa damage assessment via computerized image analysis</measure>
    <time_frame>30 days</time_frame>
    <description>Macro-morphologic inflammation and edema assessment of bladder mucosa using computerized image analysis.&#xD;
Image Analysis Technique Image of each bladder will be analyzed using FLIR Research IR Software (FLIR Systems Inc., Wilsonville, OR) to determine the proportion of inflamed areas characterized by red surface including hemorrhage and ulceration, and edema (eg, swollen smooth surface) out of total bladder area.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bladder mucosa damage urologist visual assessment</measure>
    <time_frame>30 days</time_frame>
    <description>Visual macro-morphologic inflammation and edema assessment of bladder mucosa by experienced urologists familiar with the assessment of bladder diseases. Images and videos from a first visit where the traditional Foley catheter has been in place will be compared to those from a subsequent cystoscopy. Urologists will be blinded as to the catheter associated with each block of images captured during the cystoscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient discomfort via Numeric Pain Rating Scale</measure>
    <time_frame>30 days</time_frame>
    <description>A numeric pain rating scale chart will be completed by each patient for comparison of patient discomfort with a traditional indwelling Foley catheter in patients with chronic indwelling Foley catheters. The scale runs from 0 &quot;No Pain&quot; to 5 &quot;Moderate Pain&quot; and 10 &quot;Worst Possible Pain.&quot; More information on the scale can be seen here &quot;https://www.physio-pedia.com/Numeric_Pain_Rating_Scale&quot; There are no Subscales and the marked score for first assessment will be compared to 2nd assessment to assess any changes in patient comfort with the two different catheters.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Bladder Infections and Inflammations</condition>
  <arm_group>
    <arm_group_label>Cystoscopic Inspection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Comparison of bladder damage with traditional Foley catheter and the Kohli Atraumatic catheter.&#xD;
Interventions: cystoscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>cystoscopy</intervention_name>
    <description>Comparison of bladder mucosa via cystoscopy.</description>
    <arm_group_label>Cystoscopic Inspection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or Women older than age 18&#xD;
&#xD;
          -  Indwelling Foley urinary catheter for at least 30 days prior to entry with&#xD;
             anticipation for continued indwelling urinary catheterization for at least 30 days&#xD;
             after entry into the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Unwilling or medically inappropriate for cystoscopy&#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_contact>
    <last_name>James A Greenberg, MD</last_name>
    <phone>781-910-1968</phone>
    <email>JAGREENBERG@partners.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ronald Adams, MSME</last_name>
    <phone>5089445166</phone>
    <email>ron@cystosure.com</email>
  </overall_contact_backup>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>March 25, 2019</last_update_submitted>
  <last_update_submitted_qc>March 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bladder mucosal trauma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystitis</mesh_term>
    <mesh_term>Inflammation</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/NCT03790826
org study id: CIFCAT-001
nct id: NCT03790826
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
To determine whether an indwelling low profile Kohli Atraumatic Catheter causes less
      macro-morphologic inflammation and edema to the bladder mucosa than a traditional indwelling
      Foley catheter as assess by computerized image analysis.
The Kohli Atraumatic Catheter similarly aims to reduce bladder mucosal trauma with its low
      profile pancake shaped balloon versus the ovoid balloon of a traditional Foley catheter. The
      Kohli Atraumatic Catheter has a short, opened-ended tip that minimally protrudes through a
      patented low-profile donut-shaped balloon. The combination of the low profile and reduced tip
      length prevents the catheter from contacting the bladder walls and thereby minimize
      disruption of the bladder surface mucus layer and trauma to the urothelium - theoretically
      reducing the chance of bacterial invasion. A trial in which sheep were randomized to a
      traditional indwelling Foley catheter or a prototype Kohli Atraumatic Catheter demonstrated a
      dramatic reduction in both bladder wall trauma and edema. The ulcerated area dropped from
      7.2% to 1.8% (75%) and the edema from 26.9% to 13.0% (52%).

      Statistical Analysis To compare the effects of 2 catheter types, data will be analyzed using
      the general linear models tools from SAS/STAT software and presented as means ± standard
      error of the mean. The model will include 2 catheter types, inflamed vs non-inflamed areas,
      and their interactions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Bladder mucosa damage assessment via computerized image analysis
time frame: 30 days
description: Macro-morphologic inflammation and edema assessment of bladder mucosa using computerized image analysis.
Image Analysis Technique Image of each bladder will be analyzed using FLIR Research IR Software (FLIR Systems Inc., Wilsonville, OR) to determine the proportion of inflamed areas characterized by red surface including hemorrhage and ulceration, and edema (eg, swollen smooth surface) out of total bladder area.
measure: Bladder mucosa damage urologist visual assessment
time frame: 30 days
description: Visual macro-morphologic inflammation and edema assessment of bladder mucosa by experienced urologists familiar with the assessment of bladder diseases. Images and videos from a first visit where the traditional Foley catheter has been in place will be compared to those from a subsequent cystoscopy. Urologists will be blinded as to the catheter associated with each block of images captured during the cystoscopy.
measure: Patient discomfort via Numeric Pain Rating Scale
time frame: 30 days
description: A numeric pain rating scale chart will be completed by each patient for comparison of patient discomfort with a traditional indwelling Foley catheter in patients with chronic indwelling Foley catheters. The scale runs from 0 "No Pain" to 5 "Moderate Pain" and 10 "Worst Possible Pain." More information on the scale can be seen here "https://www.physio-pedia.com/Numeric_Pain_Rating_Scale" There are no Subscales and the marked score for first assessment will be compared to 2nd assessment to assess any changes in patient comfort with the two different catheters.
arm group label: Cystoscopic Inspection
arm group type: Experimental
description: Comparison of bladder damage with traditional Foley catheter and the Kohli Atraumatic catheter.
Interventions: cystoscopy
intervention type: Device
intervention name: cystoscopy
description: Comparison of bladder mucosa via cystoscopy.
arm group label: Cystoscopic Inspection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: James A Greenberg, MD
phone: 781-910-1968
email: JAGREENBERG@partners.org
last name: Ronald Adams, MSME
phone: 5089445166
email: ron@cystosure.com
responsible party type: Sponsor
mesh term: Cystitis
mesh term: Inflammation
sharing ipd: No