<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/NCT02979808</url>
  </required_header>
  <id_info>
    <org_study_id>NAV-0001</org_study_id>
    <nct_id>NCT02979808</nct_id>
  </id_info>
  <brief_title>An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.</brief_title>
  <official_title>An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dentsply International</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wellspect HealthCare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Dentsply Sirona Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed as an open, prospective, non-controlled, qualitative, multicentre&#xD;
      study of a novel transanal irrigation system performed in a population of 150 subjects&#xD;
      suffering from spinal cord injury and confirmed neurological bowel dysfunction. The study is&#xD;
      expected to last for a total of 1 year (treatment period) with a planned 12- month&#xD;
      recruitment period and three scheduled site visits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be conducted in multiple countries, all outside of the United States. The&#xD;
      study is approved by oversight authorities in the United Kingdom, Germany, Spain, Sweden,&#xD;
      Denmark, Norway, France, and Italy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in neurogenic bowel disfunction symptoms.</measure>
    <time_frame>3 months</time_frame>
    <description>1. The primary objective of this study is to evaluate change in neurogenic bowel dysfunction symptoms between baseline and 3 months use of the Navina™ Smart system, as measured by a patient friendly version of the validated instrument NBD Score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of QoL status</measure>
    <time_frame>Baseline, 3-months, 12-months</time_frame>
    <description>To investigate the change of QoL status in the selected patient population (absolute values)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NBD symptoms</measure>
    <time_frame>6-months, 9-months, 12-months</time_frame>
    <description>To investigate NBD symptoms after 6, 9 and 12 months use of Navina Smart system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Product use compliance.</measure>
    <time_frame>3-months, 6-months, 9-months, and 12-months</time_frame>
    <description>Study product use compliance (is TAI still performed using the study device).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction assessed through patient reported outcome (PRO) variables.</measure>
    <time_frame>3-months and 12-months</time_frame>
    <description>To investigate patient perception and satisfaction of bowel management including TAI therapy and use of the Navina Smart system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of urinary tract infection (UTI).</measure>
    <time_frame>3-months and 12-months</time_frame>
    <description>Investigate frequency of UTI using patient reported outcome (PRO) variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health economic analysis utilizing QoL data.</measure>
    <time_frame>Baseline, 3-months, and 12-months.</time_frame>
    <description>To perform health economic analyses using QoL data (EQ-5D).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health economic analysis utilizing patient reported outcome (PRO) variables.</measure>
    <time_frame>Baseline, 3-months, and 12-months.</time_frame>
    <description>To perform health economic analyses using PRO variables.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thematic analysis of interview data.</measure>
    <time_frame>Baseline, 3-months, and 12-months (or at end of treatment period).</time_frame>
    <description>To understand individual experience of initiating and using TAI for neurogenic bowel dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thematic analysis of interview data.</measure>
    <time_frame>Baseline, 3-months, and 12-months (or at end of treatment period).</time_frame>
    <description>To explore individual perceptions of using TAI compared with other conservative treatments for neurogenic bowel dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thematic analysis of interview data.</measure>
    <time_frame>Baseline, 3-months, and 12-months (or at end of treatment period).</time_frame>
    <description>To explore what influences individuals to continue with or stop using TAI for neurogenic bowel dysfunction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events, serious adverse events, and adverse device effects.</measure>
    <time_frame>3-months, 6-months, 9-months, 12-months</time_frame>
    <description>To evaluate short- and long-term safety of the product and therapy by assessing adverse events, serious adverse events, adverse device effects.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Neurogenic Bowel</condition>
  <arm_group>
    <arm_group_label>Navina Smart</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Navina Smart will be used during 12 months for transanal irrigation (TAI).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Navina Smart</intervention_name>
    <description>Subjects treatment-naïve to transanal irrigation (TAI). Frequency of TAI will be tailored to each subject.</description>
    <arm_group_label>Navina Smart</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of informed consent.&#xD;
&#xD;
          2. Male or female aged 18 years or older.&#xD;
&#xD;
          3. Patient with previously confirmed chronic spinal cord injury, either:&#xD;
&#xD;
               1. Traumatic; at any level and any completeness of injury and ASIA grade&#xD;
                  classification, or&#xD;
&#xD;
               2. Non-traumatic; due to infection, inflammation (i.e.; transverse myelitis or&#xD;
                  ischaemic myelitis), compromised blood supply, a post-ischemic state, etc.&#xD;
&#xD;
          4. At least 3 months post spinal cord injury at time of consent.&#xD;
&#xD;
          5. NBD score ≥10, confirmed at Baseline .&#xD;
&#xD;
          6. Only TAI treatment - naïve patient (not having previously used any particular&#xD;
             transanal irrigation system, e.g. Peristeen®).&#xD;
&#xD;
          7. Confirmed NBD refractory to conservative therapy and judged eligible for transanal&#xD;
             irrigation as per standardised treatment pathway 18.&#xD;
&#xD;
          8. Able to handle smartphone/tablet.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any confirmed or suspected diagnosis of anal or rectal stenosis, active inflammatory&#xD;
             bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer,&#xD;
             ischemic colitis, history of life-threatening autonomic dysreflexia, bleeding&#xD;
             disorders, unspecified peri-anal conditions.&#xD;
&#xD;
          2. Untreated rectal impaction.&#xD;
&#xD;
          3. Any radiotherapy to the pelvis.&#xD;
&#xD;
          4. Any current treatment with anticoagulants (not including aspirin or clopidogrel).&#xD;
&#xD;
          5. Any current treatment with long-term systemic steroid medication (not including&#xD;
             inhalation agents and/or local topical treatment).&#xD;
&#xD;
          6. Current use of prokinetics.&#xD;
&#xD;
          7. Any prior rectal or colonic surgery (not including anal procedures &gt;3 months ago, e.g.&#xD;
             haemorrhoid excision).&#xD;
&#xD;
          8. Anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks.&#xD;
&#xD;
          9. Overt or planned pregnancy.&#xD;
&#xD;
         10. Ongoing symptomatic UTI as judged by investigator.&#xD;
&#xD;
         11. Diagnosed psychiatric illness, considered as unstable by the investigator.&#xD;
&#xD;
         12. Diagnosed with MS.&#xD;
&#xD;
         13. Involvement in the planning and conduct of the study (applies to both WHC staff and&#xD;
             staff at the study site).&#xD;
&#xD;
         14. Previous enrolment in the present study.&#xD;
&#xD;
         15. Simultaneous participation in another clinical study that may interfere with the&#xD;
             present study.&#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>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital St Jacques</name>
      <address>
        <city>Nantes</city>
        <state>Rennes</state>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zentralklinik Bad Berka Gmbh</name>
      <address>
        <city>Bad Berka</city>
        <zip>99437</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BG-Klinikum Hamburg</name>
      <address>
        <city>Hamburg</city>
        <zip>21033</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montecatone Rehabilitation Institute, Università di Bologna</name>
      <address>
        <city>Imola</city>
        <state>Bologna</state>
        <zip>40026</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera- Universitaria Careggi</name>
      <address>
        <city>Firenze</city>
        <state>Florence</state>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnaas Sykehus HF</name>
      <address>
        <city>Nesoddtangen</city>
        <zip>1450</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad de Lesionados Medulares Hospital Traumatología</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario A Coruña</name>
      <address>
        <city>Coruna</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurologiska kliniken, Avd R18 Karolinska Universitetssjukhuset, Solna</name>
      <address>
        <city>Stockholm</city>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastrointestinal Physiology Unit, University College London Hospital</name>
      <address>
        <city>London</city>
        <zip>NW1 2BU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Norway</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>December 11, 2019</last_update_submitted>
  <last_update_submitted_qc>December 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurogenic Bowel</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/NCT02979808
org study id: NAV-0001
nct id: NCT02979808
lead sponsor: 
collaborator: 
has dmc: No
This study is designed as an open, prospective, non-controlled, qualitative, multicentre
      study of a novel transanal irrigation system performed in a population of 150 subjects
      suffering from spinal cord injury and confirmed neurological bowel dysfunction. The study is
      expected to last for a total of 1 year (treatment period) with a planned 12- month
      recruitment period and three scheduled site visits.
This study will be conducted in multiple countries, all outside of the United States. The
      study is approved by oversight authorities in the United Kingdom, Germany, Spain, Sweden,
      Denmark, Norway, France, and Italy
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in neurogenic bowel disfunction symptoms.
time frame: 3 months
description: 1. The primary objective of this study is to evaluate change in neurogenic bowel dysfunction symptoms between baseline and 3 months use of the Navina™ Smart system, as measured by a patient friendly version of the validated instrument NBD Score.
measure: Change of QoL status
time frame: Baseline, 3-months, 12-months
description: To investigate the change of QoL status in the selected patient population (absolute values)
measure: NBD symptoms
time frame: 6-months, 9-months, 12-months
description: To investigate NBD symptoms after 6, 9 and 12 months use of Navina Smart system
measure: Product use compliance.
time frame: 3-months, 6-months, 9-months, and 12-months
description: Study product use compliance (is TAI still performed using the study device).
measure: Patient satisfaction assessed through patient reported outcome (PRO) variables.
time frame: 3-months and 12-months
description: To investigate patient perception and satisfaction of bowel management including TAI therapy and use of the Navina Smart system.
measure: Frequency of urinary tract infection (UTI).
time frame: 3-months and 12-months
description: Investigate frequency of UTI using patient reported outcome (PRO) variables.
measure: Health economic analysis utilizing QoL data.
time frame: Baseline, 3-months, and 12-months.
description: To perform health economic analyses using QoL data (EQ-5D).
measure: Health economic analysis utilizing patient reported outcome (PRO) variables.
time frame: Baseline, 3-months, and 12-months.
description: To perform health economic analyses using PRO variables.
measure: Thematic analysis of interview data.
time frame: Baseline, 3-months, and 12-months (or at end of treatment period).
description: To understand individual experience of initiating and using TAI for neurogenic bowel dysfunction.
measure: Thematic analysis of interview data.
time frame: Baseline, 3-months, and 12-months (or at end of treatment period).
description: To explore individual perceptions of using TAI compared with other conservative treatments for neurogenic bowel dysfunction.
measure: Thematic analysis of interview data.
time frame: Baseline, 3-months, and 12-months (or at end of treatment period).
description: To explore what influences individuals to continue with or stop using TAI for neurogenic bowel dysfunction.
measure: Incidence of adverse events, serious adverse events, and adverse device effects.
time frame: 3-months, 6-months, 9-months, 12-months
description: To evaluate short- and long-term safety of the product and therapy by assessing adverse events, serious adverse events, adverse device effects.
arm group label: Navina Smart
arm group type: Experimental
description: Navina Smart will be used during 12 months for transanal irrigation (TAI).
intervention type: Device
intervention name: Navina Smart
description: Subjects treatment-naïve to transanal irrigation (TAI). Frequency of TAI will be tailored to each subject.
arm group label: Navina Smart
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
country: France
country: Germany
country: Italy
country: Norway
country: Spain
country: Sweden
country: United Kingdom
responsible party type: Sponsor
mesh term: Neurogenic Bowel
sharing ipd: No