<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/NCT04438499</url>
  </required_header>
  <id_info>
    <org_study_id>ESNS-PH01</org_study_id>
    <nct_id>NCT04438499</nct_id>
  </id_info>
  <brief_title>e۰Sense® Catheter Clinical Investigation</brief_title>
  <official_title>e۰Sense® Clinical Investigation: Assessing the Performance, Safety and Usability of e۰Sense® Electronic Catheters for Performing Urodynamic Studies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laborie Medical Technologies Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laborie Medical Technologies Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pre-market study will be conducted on consenting patients undergoing a medically&#xD;
      prescribed, invasive, conventional urodynamics (UDS) test using the investigational device&#xD;
      (e۰Sense® urodynamic catheters). Data pertaining to the safety, effectiveness and usability&#xD;
      of the catheters will be collected.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will recruit and consent up to 65 subjects from up to 4 different sites (minimum 15&#xD;
      subjects recruited at each site) in the European Union, and the expected duration of each&#xD;
      subject's participation is one clinic visit to receive their already requested UDS test. A&#xD;
      follow-up call will be conducted three to five days later to collect adverse event&#xD;
      information post-test. An interim analysis is to be performed when data from 30 patients has&#xD;
      been completed to support the primary objective, and using the results for regulatory&#xD;
      purposes (e.g. CE marking). However, the study enrollment continues, during the interim&#xD;
      analysis, until 60 patients (maximum 65) have been recruited and all data collected. At the&#xD;
      end of the study, the data will be analysed against secondary and exploratory objectives&#xD;
      including an exploratory analysis of the primary objective on all patients.&#xD;
&#xD;
      To collect data for the study, Case Report Forms (CRF) have been developed. They will be&#xD;
      paper based and do not include any patient identifiers except a Site Subject ID. Any document&#xD;
      linking the Site Subject ID to subject information will be stored at the site and not shared&#xD;
      with the sponsor. Additionally, CRF completion guidelines will be developed prior to study&#xD;
      initiation to aid correct and consistent data collection. These guidelines will be provided&#xD;
      to the site and site personnel will be trained prior to subject enrollment. CRFs will be&#xD;
      treated as source data in the event that the original information is entered on the CRFs&#xD;
      first, and no source document worksheet is utilized for that data point. Laborie will enter&#xD;
      CRF data in to an excel database that has been developed to represent each field on the CRF.&#xD;
      Data Management activities are conducted in accordance with Laborie's Data Management Plan,&#xD;
      including but not limited to: source data verification (monitoring), query handling and&#xD;
      resolution, data entry quality control and controlled database locking. Guidelines have also&#xD;
      been created that contain detailed descriptions of each data entry point and how to enter in&#xD;
      the database.&#xD;
&#xD;
      The data from the CRFs will be used to make the following assessments:&#xD;
&#xD;
        -  The investigator will be asked to make an assessment to determine the safety and&#xD;
           performance of the device regarding the intended use.&#xD;
&#xD;
        -  A Numeric Pain Rating Scale (NPRS) will be used to assess the parameters of patient&#xD;
           discomfort/pain, if appropriate.&#xD;
&#xD;
        -  All adverse events will be recorded to assess the safety of the device.&#xD;
&#xD;
        -  Subjective questionnaire completed by the user to assess ease of use, ease of insertion&#xD;
           and removal, ease of securing the catheter, tracing stability (overall, during filling,&#xD;
           voiding and UPP where applicable), tracing quality (overall, Pves, Pabd, Pura where&#xD;
           applicable), channel subtraction quality, visibility on Video Urodynamics (VUDS, where&#xD;
           applicable), catheter stiffness, sensor location, patient tolerance, and overall&#xD;
           usability performance.&#xD;
&#xD;
        -  Pre-test at various positions and resting pressures through the study&#xD;
&#xD;
        -  The de-identified urodynamic data files will be collected and stored&#xD;
&#xD;
      Risks to the patient will be no greater than those of a standard Urodynamics test. Patients&#xD;
      may experience temporary discomfort upon insertion of the catheters. Test duration may be&#xD;
      slightly longer than a standard test while assessment of the study materials is being made,&#xD;
      and so discomfort and inconvenience associated with an extended test duration may occur.&#xD;
      Furthermore, bladder catheterization can increase the risk of urinary tract infection, but&#xD;
      with no higher incidence than during standard urodynamics. No patient follow-up visit is&#xD;
      scheduled for this study, unless deemed necessary by the physician in the event of adverse&#xD;
      event(s).&#xD;
&#xD;
      Monitors are appointed by Laborie and are appropriately trained with scientific and/or&#xD;
      clinical knowledge needed to monitor the trial adequately. The monitors are also thoroughly&#xD;
      familiar with the investigational medical device under investigation, the protocol, written&#xD;
      informed consent form (ICF), and any other written information to be provided to subjects,&#xD;
      Laborie standard operating procedures, ISO 14155, and GCP.&#xD;
&#xD;
      The monitor conducts activities per Laborie's Monitoring Plan, including but not limited to:&#xD;
&#xD;
        -  Acting as the main line of communication between the sponsor and the investigator.&#xD;
&#xD;
        -  Verifying that the investigator has adequate qualifications, number of subjects, and&#xD;
           resources and remain adequate throughout the trial period, and that facilities are&#xD;
           adequate to safely and properly conduct the trial and remain adequate through the trial&#xD;
           period.&#xD;
&#xD;
        -  Initiating each participating sites&#xD;
&#xD;
        -  Ensuring the investigational device is being used according to the protocol and&#xD;
           instructions for use&#xD;
&#xD;
        -  Verifying that the investigator and investigation site team understands and follows the&#xD;
           approved protocol and all approved amendments (if any).&#xD;
&#xD;
        -  Verifying that the investigator is familiar with the responsibilities of the principal&#xD;
           investigator.&#xD;
&#xD;
        -  Ensuring the investigator and site team are informed and knowledgeable of all relevant&#xD;
           document updates concerning the clinical trial.&#xD;
&#xD;
        -  Ensuring that the investigator receives the most up-to-date copy of the Investigator's&#xD;
           Brochure, all documents, and all trial supplies needed to conduct the trial properly and&#xD;
           to comply with the applicable regulatory requirements.&#xD;
&#xD;
        -  Verifying that only authorized and trained site personnel are participating in the&#xD;
           clinical trial.&#xD;
&#xD;
        -  Verifying that source data and other records are accurate, complete, up to date, stored,&#xD;
           and maintained appropriately.&#xD;
&#xD;
        -  Signed and dated informed consent forms have been obtained from each subject at the&#xD;
           point of enrolment or before any clinical-investigation-related procedures are&#xD;
           performed.&#xD;
&#xD;
        -  Verifying that CRFs and queries are complete, recorded in a timely manner, and&#xD;
           consistent with SD.&#xD;
&#xD;
        -  Verifying that appropriate corrections, additions, or deletions are made to the CRFs,&#xD;
           dated, explained if necessary and initiated by the authorized designee. The monitor&#xD;
           shall NOT make corrections, additions, or deletions to the CRFs.&#xD;
&#xD;
        -  Ensuring all adverse events (AEs) and device deficiencies (DDs) are reported to the&#xD;
           sponsor and all serious AEs as well as DDs that could have led to serious adverse device&#xD;
           events are reported to the sponsor without unjustified delay.&#xD;
&#xD;
        -  Verifying that subject withdrawal has been documented and that subject or site&#xD;
           non-compliance with the requirements has been documented.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Anticipated">September 2022</completion_date>
  <primary_completion_date type="Actual">December 17, 2020</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>
    <intervention_model_description>There will be no control arm or blinding in this trial or inclusion of a sham or placebo, as it is not applicable to the study design.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinician Safety and Effectiveness Rating of eSense Catheters (Per Patient)</measure>
    <time_frame>approximately 60 minutes</time_frame>
    <description>The primary objective of the study is to gather clinical data to confirm that the updated e۰Sense® catheters are safe and effective for urodynamic use in subjects medically indicated for urodynamics testing.&#xD;
The primary outcome will be measured by recording the clinician safety and effectiveness rating for each subject on their CRF. The clinicians will indicate whether each of the e۰Sense® bladder and abdominal catheters are safe &amp; effective for urodynamic use. Given the intended use of the device, and the fact that there is no single or combined objective measures generated from the UDS test that can establish the safety and effectiveness, it is justified to obtain clinicians' feedback via a binary response whether the device is safe and effective for urodynamic use.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To Report the Severe Complication-free Rate for the Updated e۰Sense Catheters.</measure>
    <time_frame>approximately 60 minutes</time_frame>
    <description>Outcome not included in a priori interim analysis plan as per the protocol. The secondary outcome will be measured by recording the number of severe complications and serious adverse events (as defined in the protocol) for each subject on their CRF. Due to the low risk profile of UDS, the sponsor would like to report the severe complication-free rate for any severe complications associated with UDS, and therefore this secondary safety endpoint was planned. Additionally, the sponsor would like to collect and assess this information due to a lack of available published data using the e۰Sense® catheter technology.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Assess User Impression Based on Subjective Measures</measure>
    <time_frame>approximately 60 minutes</time_frame>
    <description>Outcome not included in a priori interim analysis plan as per the protocol. Assess user impressions of the updated e۰Sense® catheters compared with their experience using the existing catheters at each site, by evaluating the following subjective measures: ease of use, ease of insertion and removal, ease of securing the catheter, tracing stability, tracing quality , channel subtraction quality, visibility on VUDS (where applicable), catheter stiffness, sensor location, subject tolerance, and overall usability performance.&#xD;
This exploratory endpoint will be measured by collecting usability data in a questionnaire format. At the end of each clinic day a trained clinical user shall complete the questionnaire. When evaluating the usability of a device, the sponsor feels it's appropriate to use a subjective ordinal scale response while assessing human and device usability factors.</description>
  </other_outcome>
  <other_outcome>
    <measure>Asses Subjective Discomfort Levels in the Study Population</measure>
    <time_frame>approximately 60 minutes</time_frame>
    <description>Outcome not included in a priori interim analysis plan as per the protocol. Assess subjective subject feedback regarding their discomfort and pain levels. This exploratory endpoint will be measured by collecting subject feedback regarding the level of discomfort and pain experienced during their Urodynamic test using the Numerical Pain Rating Scale (NPRS). Subjects will grade their discomfort/pain on the NPRS from 0 (&quot;No Pain&quot;) to 10 (&quot;Worst Pain&quot;). Given the subject population, use of the NPRS is a validated tool in evaluating pain ratings in adults.</description>
  </other_outcome>
  <other_outcome>
    <measure>Assess Resting Pressures in the Subject Before Urodynamics</measure>
    <time_frame>approximately 60 minutes</time_frame>
    <description>Outcome not included in a priori interim analysis plan as per the protocol. This exploratory endpoint will be measured by recording initial resting pressures (in cmH20) using the updated e۰Sense® catheters while each subject is positioned in a sitting, standing and supine position, if patient mobility allows. Resting pressures will be recorded on each subjects' CRF 1 during their urodynamics visit.</description>
  </other_outcome>
  <other_outcome>
    <measure>Assess Resting Pressure at Different Filling and Emptying Volumes</measure>
    <time_frame>approximately 60 minutes</time_frame>
    <description>Outcome not included in a priori interim analysis plan as per the protocol. This exploratory endpoint will be measured by recording resting pressures (in cmH20) using the updated e۰Sense® catheters during various points of the UDS test as applicable (every 100 mL of filling, MCC, and post-void) at the recorded patient position (sitting, standing, or supine). Patients are to remain in the same position throughout, however supplemental positions can be used (e.g. performing provocative manoeuvres). Resting pressures and patient position will be recorded on each subjects' CRF 1 during their urodynamics visit.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Urodynamics</condition>
  <arm_group>
    <arm_group_label>Subjects Indicated for a UDS study</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The investigational device, i.e. the eSense catheter will be used in all the subjects to assess primary and exploratory objectives. It is a single arm study with no comparative, placebo, sham or control arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>eSense 7fr Single Sensor Bladder Catheter</intervention_name>
    <description>Urinary and abdominal catheters inserted in to the body to measure pressure for urodynamics.</description>
    <arm_group_label>Subjects Indicated for a UDS study</arm_group_label>
    <other_name>eSense 7Fr Abdominal Catheters</other_name>
    <other_name>eSense 7Fr Dual Sensor Urethral Catheters</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and Female subjects (Age: 21 years and over) who are medically indicated for UDS&#xD;
             testing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with significant cognitive deficiency that prevent the subject from giving&#xD;
             informed consent&#xD;
&#xD;
          -  Subjects suffering from an active bladder infection (not including subjects with&#xD;
             asymptomatic bacteriuria)&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Subjects with recent (less than 2 weeks) pelvic floor surgery&#xD;
&#xD;
          -  Subjects who require the use of a suprapubic catheter&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruth Kirschner-Hermanns, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rehabilitationszentrum Godeshöhe</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rehabilitationszentrum Godeshöhe</name>
      <address>
        <city>Bonn</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Fleiss, J.L., Levin, B., &amp; Cho Paik, M. (2003). Statistical Methods for Rates and Proportions (3rd ed.). New York, NY: Wiley</citation>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <results_first_submitted>December 8, 2021</results_first_submitted>
  <results_first_submitted_qc>August 15, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 7, 2022</results_first_posted>
  <last_update_submitted>August 15, 2022</last_update_submitted>
  <last_update_submitted_qc>August 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>urodynamics</keyword>
  <keyword>urinary catheter</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 24, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT04438499/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment completed at one site up to interim analysis from June to Dec, 2020.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Subjects Medically Indicated for a Urodynamics (UDS) Study</title>
          <description>The investigational device, i.e. the eSense catheter will be used in all the subjects to assess primary and exploratory objectives. It is a single arm study with no comparative, placebo, sham or control arm.&#xD;
eSense 7fr Catheters: A bladder and abdominal catheter are inserted in to the body to measure pressure for urodynamics.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31">31 participants represent the sensitivity analysis (intent to treat) population. Since there was a lack of efficacy in one participant which was determined to be due to anatomical factors (catheterization was unsuccessful), one additional participant was enrolled to meet the minimum requirement of 30 primary analysis population participants.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29">29 of 31 participants completed the study. One enrolled participant did not complete the study due to anatomical factors preventing catheterization and this participant was replaced to meet the minimum required 30 primary analysis population participants. A second enrolled participant did not complete the study due to a device deficiency and failure of the catheter during the procedure.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All eligible subjects medically indicated for a urodynamics (UDS) study are included in the baseline analysis population.</population>
      <group_list>
        <group group_id="B1">
          <title>Subjects Medically Indicated for a Urodynamics (UDS) Study</title>
          <description>The investigational device, i.e. the eSense catheter will be used in all the subjects to assess primary and exploratory objectives. It is a single arm study with no comparative, placebo, sham or control arm.&#xD;
eSense 7fr Catheters: A bladder and abdominal catheter are inserted in to the body to measure pressure for urodynamics.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="31"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52.9" lower_limit="31" upper_limit="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Clinician Safety and Effectiveness Rating of eSense Catheters (Per Patient)</title>
        <description>The primary objective of the study is to gather clinical data to confirm that the updated e۰Sense® catheters are safe and effective for urodynamic use in subjects medically indicated for urodynamics testing.&#xD;
The primary outcome will be measured by recording the clinician safety and effectiveness rating for each subject on their CRF. The clinicians will indicate whether each of the e۰Sense® bladder and abdominal catheters are safe &amp; effective for urodynamic use. Given the intended use of the device, and the fact that there is no single or combined objective measures generated from the UDS test that can establish the safety and effectiveness, it is justified to obtain clinicians' feedback via a binary response whether the device is safe and effective for urodynamic use.</description>
        <time_frame>approximately 60 minutes</time_frame>
        <population>31 participants represent the sensitivity analysis (intent to treat) population. 29 of 31 participants completed the study. One participant had anatomical factors which prevented device insertion and procedure could not be performed. Thus, one additional participant was enrolled to meet the minimum requirement of 30 primary analysis population participants. Among these 30, one participant did not complete the study due to a device deficiency and failure of the catheter during the procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>Subjects Medically Indicated for a UDS Study</title>
            <description>The investigational device, i.e. the eSense catheter will be used in all the subjects to assess primary and exploratory objectives. It is a single arm study with no comparative, placebo, sham or control arm.&#xD;
eSense 7fr Single Sensor Bladder Catheter: Urinary and abdominal catheters inserted in to the body to measure pressure for urodynamics.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinician Safety and Effectiveness Rating of eSense Catheters (Per Patient)</title>
          <description>The primary objective of the study is to gather clinical data to confirm that the updated e۰Sense® catheters are safe and effective for urodynamic use in subjects medically indicated for urodynamics testing.&#xD;
The primary outcome will be measured by recording the clinician safety and effectiveness rating for each subject on their CRF. The clinicians will indicate whether each of the e۰Sense® bladder and abdominal catheters are safe &amp; effective for urodynamic use. Given the intended use of the device, and the fact that there is no single or combined objective measures generated from the UDS test that can establish the safety and effectiveness, it is justified to obtain clinicians' feedback via a binary response whether the device is safe and effective for urodynamic use.</description>
          <population>31 participants represent the sensitivity analysis (intent to treat) population. 29 of 31 participants completed the study. One participant had anatomical factors which prevented device insertion and procedure could not be performed. Thus, one additional participant was enrolled to meet the minimum requirement of 30 primary analysis population participants. Among these 30, one participant did not complete the study due to a device deficiency and failure of the catheter during the procedure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>To Report the Severe Complication-free Rate for the Updated e۰Sense Catheters.</title>
        <description>Outcome not included in a priori interim analysis plan as per the protocol. The secondary outcome will be measured by recording the number of severe complications and serious adverse events (as defined in the protocol) for each subject on their CRF. Due to the low risk profile of UDS, the sponsor would like to report the severe complication-free rate for any severe complications associated with UDS, and therefore this secondary safety endpoint was planned. Additionally, the sponsor would like to collect and assess this information due to a lack of available published data using the e۰Sense® catheter technology.</description>
        <time_frame>approximately 60 minutes</time_frame>
        <posting_date>01/2023</posting_date>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Assess User Impression Based on Subjective Measures</title>
        <description>Outcome not included in a priori interim analysis plan as per the protocol. Assess user impressions of the updated e۰Sense® catheters compared with their experience using the existing catheters at each site, by evaluating the following subjective measures: ease of use, ease of insertion and removal, ease of securing the catheter, tracing stability, tracing quality , channel subtraction quality, visibility on VUDS (where applicable), catheter stiffness, sensor location, subject tolerance, and overall usability performance.&#xD;
This exploratory endpoint will be measured by collecting usability data in a questionnaire format. At the end of each clinic day a trained clinical user shall complete the questionnaire. When evaluating the usability of a device, the sponsor feels it's appropriate to use a subjective ordinal scale response while assessing human and device usability factors.</description>
        <time_frame>approximately 60 minutes</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Asses Subjective Discomfort Levels in the Study Population</title>
        <description>Outcome not included in a priori interim analysis plan as per the protocol. Assess subjective subject feedback regarding their discomfort and pain levels. This exploratory endpoint will be measured by collecting subject feedback regarding the level of discomfort and pain experienced during their Urodynamic test using the Numerical Pain Rating Scale (NPRS). Subjects will grade their discomfort/pain on the NPRS from 0 (&quot;No Pain&quot;) to 10 (&quot;Worst Pain&quot;). Given the subject population, use of the NPRS is a validated tool in evaluating pain ratings in adults.</description>
        <time_frame>approximately 60 minutes</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Assess Resting Pressures in the Subject Before Urodynamics</title>
        <description>Outcome not included in a priori interim analysis plan as per the protocol. This exploratory endpoint will be measured by recording initial resting pressures (in cmH20) using the updated e۰Sense® catheters while each subject is positioned in a sitting, standing and supine position, if patient mobility allows. Resting pressures will be recorded on each subjects' CRF 1 during their urodynamics visit.</description>
        <time_frame>approximately 60 minutes</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Assess Resting Pressure at Different Filling and Emptying Volumes</title>
        <description>Outcome not included in a priori interim analysis plan as per the protocol. This exploratory endpoint will be measured by recording resting pressures (in cmH20) using the updated e۰Sense® catheters during various points of the UDS test as applicable (every 100 mL of filling, MCC, and post-void) at the recorded patient position (sitting, standing, or supine). Patients are to remain in the same position throughout, however supplemental positions can be used (e.g. performing provocative manoeuvres). Resting pressures and patient position will be recorded on each subjects' CRF 1 during their urodynamics visit.</description>
        <time_frame>approximately 60 minutes</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The duration of each patient's participation was one clinic visit with a follow-up call 3-5 days later, after which their involvement in the study ended.</time_frame>
      <desc>Referencing the Medical Device Safety Plan Ordinance (MPSV) under German law:&#xD;
Serious Adverse Event - MPSV § 2 (5) English: A serious adverse event (SAE) is any undesired event occurring in a clinical investigation or a performance evaluation study requiring an authorization, which has led, or could have led, or could lead directly or indirectly to the death or severe health impairment of volunteers, users or other persons regardless of whether the event was caused by the medical device.</desc>
      <group_list>
        <group group_id="E1">
          <title>Subjects Medically Indicated for a Urodynamics (UDS) Study</title>
          <description>The investigational device, i.e. the eSense catheter will be used in all the subjects to assess primary and exploratory objectives. It is a single arm study with no comparative, placebo, sham or control arm.&#xD;
eSense 7fr Catheters: A bladder and abdominal catheter are inserted in to the body to measure pressure for urodynamics.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Mild discomfort in the urethra</sub_title>
                <description>Mild discomfort in the urethra following catheterization that was short lasting and resolved without intervention.</description>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Mild macrohematuria</sub_title>
                <description>Small amount of blood when passing urine.</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Adele Campbell</name_or_title>
      <organization>Laborie Medical Technologies</organization>
      <phone>16032558251</phone>
      <email>ACampbell@laborie.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04438499
org study id: ESNS-PH01
nct id: NCT04438499
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pre-market study will be conducted on consenting patients undergoing a medically
      prescribed, invasive, conventional urodynamics (UDS) test using the investigational device
      (e۰Sense® urodynamic catheters). Data pertaining to the safety, effectiveness and usability
      of the catheters will be collected.
The study will recruit and consent up to 65 subjects from up to 4 different sites (minimum 15
      subjects recruited at each site) in the European Union, and the expected duration of each
      subject's participation is one clinic visit to receive their already requested UDS test. A
      follow-up call will be conducted three to five days later to collect adverse event
      information post-test. An interim analysis is to be performed when data from 30 patients has
      been completed to support the primary objective, and using the results for regulatory
      purposes (e.g. CE marking). However, the study enrollment continues, during the interim
      analysis, until 60 patients (maximum 65) have been recruited and all data collected. At the
      end of the study, the data will be analysed against secondary and exploratory objectives
      including an exploratory analysis of the primary objective on all patients.

      To collect data for the study, Case Report Forms (CRF) have been developed. They will be
      paper based and do not include any patient identifiers except a Site Subject ID. Any document
      linking the Site Subject ID to subject information will be stored at the site and not shared
      with the sponsor. Additionally, CRF completion guidelines will be developed prior to study
      initiation to aid correct and consistent data collection. These guidelines will be provided
      to the site and site personnel will be trained prior to subject enrollment. CRFs will be
      treated as source data in the event that the original information is entered on the CRFs
      first, and no source document worksheet is utilized for that data point. Laborie will enter
      CRF data in to an excel database that has been developed to represent each field on the CRF.
      Data Management activities are conducted in accordance with Laborie's Data Management Plan,
      including but not limited to: source data verification (monitoring), query handling and
      resolution, data entry quality control and controlled database locking. Guidelines have also
      been created that contain detailed descriptions of each data entry point and how to enter in
      the database.

      The data from the CRFs will be used to make the following assessments:

        -  The investigator will be asked to make an assessment to determine the safety and
           performance of the device regarding the intended use.

        -  A Numeric Pain Rating Scale (NPRS) will be used to assess the parameters of patient
           discomfort/pain, if appropriate.

        -  All adverse events will be recorded to assess the safety of the device.

        -  Subjective questionnaire completed by the user to assess ease of use, ease of insertion
           and removal, ease of securing the catheter, tracing stability (overall, during filling,
           voiding and UPP where applicable), tracing quality (overall, Pves, Pabd, Pura where
           applicable), channel subtraction quality, visibility on Video Urodynamics (VUDS, where
           applicable), catheter stiffness, sensor location, patient tolerance, and overall
           usability performance.

        -  Pre-test at various positions and resting pressures through the study

        -  The de-identified urodynamic data files will be collected and stored

      Risks to the patient will be no greater than those of a standard Urodynamics test. Patients
      may experience temporary discomfort upon insertion of the catheters. Test duration may be
      slightly longer than a standard test while assessment of the study materials is being made,
      and so discomfort and inconvenience associated with an extended test duration may occur.
      Furthermore, bladder catheterization can increase the risk of urinary tract infection, but
      with no higher incidence than during standard urodynamics. No patient follow-up visit is
      scheduled for this study, unless deemed necessary by the physician in the event of adverse
      event(s).

      Monitors are appointed by Laborie and are appropriately trained with scientific and/or
      clinical knowledge needed to monitor the trial adequately. The monitors are also thoroughly
      familiar with the investigational medical device under investigation, the protocol, written
      informed consent form (ICF), and any other written information to be provided to subjects,
      Laborie standard operating procedures, ISO 14155, and GCP.

      The monitor conducts activities per Laborie's Monitoring Plan, including but not limited to:

        -  Acting as the main line of communication between the sponsor and the investigator.

        -  Verifying that the investigator has adequate qualifications, number of subjects, and
           resources and remain adequate throughout the trial period, and that facilities are
           adequate to safely and properly conduct the trial and remain adequate through the trial
           period.

        -  Initiating each participating sites

        -  Ensuring the investigational device is being used according to the protocol and
           instructions for use

        -  Verifying that the investigator and investigation site team understands and follows the
           approved protocol and all approved amendments (if any).

        -  Verifying that the investigator is familiar with the responsibilities of the principal
           investigator.

        -  Ensuring the investigator and site team are informed and knowledgeable of all relevant
           document updates concerning the clinical trial.

        -  Ensuring that the investigator receives the most up-to-date copy of the Investigator's
           Brochure, all documents, and all trial supplies needed to conduct the trial properly and
           to comply with the applicable regulatory requirements.

        -  Verifying that only authorized and trained site personnel are participating in the
           clinical trial.

        -  Verifying that source data and other records are accurate, complete, up to date, stored,
           and maintained appropriately.

        -  Signed and dated informed consent forms have been obtained from each subject at the
           point of enrolment or before any clinical-investigation-related procedures are
           performed.

        -  Verifying that CRFs and queries are complete, recorded in a timely manner, and
           consistent with SD.

        -  Verifying that appropriate corrections, additions, or deletions are made to the CRFs,
           dated, explained if necessary and initiated by the authorized designee. The monitor
           shall NOT make corrections, additions, or deletions to the CRFs.

        -  Ensuring all adverse events (AEs) and device deficiencies (DDs) are reported to the
           sponsor and all serious AEs as well as DDs that could have led to serious adverse device
           events are reported to the sponsor without unjustified delay.

        -  Verifying that subject withdrawal has been documented and that subject or site
           non-compliance with the requirements has been documented.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: There will be no control arm or blinding in this trial or inclusion of a sham or placebo, as it is not applicable to the study design.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Clinician Safety and Effectiveness Rating of eSense Catheters (Per Patient)
time frame: approximately 60 minutes
description: The primary objective of the study is to gather clinical data to confirm that the updated e۰Sense® catheters are safe and effective for urodynamic use in subjects medically indicated for urodynamics testing.
The primary outcome will be measured by recording the clinician safety and effectiveness rating for each subject on their CRF. The clinicians will indicate whether each of the e۰Sense® bladder and abdominal catheters are safe & effective for urodynamic use. Given the intended use of the device, and the fact that there is no single or combined objective measures generated from the UDS test that can establish the safety and effectiveness, it is justified to obtain clinicians' feedback via a binary response whether the device is safe and effective for urodynamic use.
measure: To Report the Severe Complication-free Rate for the Updated e۰Sense Catheters.
time frame: approximately 60 minutes
description: Outcome not included in a priori interim analysis plan as per the protocol. The secondary outcome will be measured by recording the number of severe complications and serious adverse events (as defined in the protocol) for each subject on their CRF. Due to the low risk profile of UDS, the sponsor would like to report the severe complication-free rate for any severe complications associated with UDS, and therefore this secondary safety endpoint was planned. Additionally, the sponsor would like to collect and assess this information due to a lack of available published data using the e۰Sense® catheter technology.
measure: Assess User Impression Based on Subjective Measures
time frame: approximately 60 minutes
description: Outcome not included in a priori interim analysis plan as per the protocol. Assess user impressions of the updated e۰Sense® catheters compared with their experience using the existing catheters at each site, by evaluating the following subjective measures: ease of use, ease of insertion and removal, ease of securing the catheter, tracing stability, tracing quality , channel subtraction quality, visibility on VUDS (where applicable), catheter stiffness, sensor location, subject tolerance, and overall usability performance.
This exploratory endpoint will be measured by collecting usability data in a questionnaire format. At the end of each clinic day a trained clinical user shall complete the questionnaire. When evaluating the usability of a device, the sponsor feels it's appropriate to use a subjective ordinal scale response while assessing human and device usability factors.
measure: Asses Subjective Discomfort Levels in the Study Population
time frame: approximately 60 minutes
description: Outcome not included in a priori interim analysis plan as per the protocol. Assess subjective subject feedback regarding their discomfort and pain levels. This exploratory endpoint will be measured by collecting subject feedback regarding the level of discomfort and pain experienced during their Urodynamic test using the Numerical Pain Rating Scale (NPRS). Subjects will grade their discomfort/pain on the NPRS from 0 ("No Pain") to 10 ("Worst Pain"). Given the subject population, use of the NPRS is a validated tool in evaluating pain ratings in adults.
measure: Assess Resting Pressures in the Subject Before Urodynamics
time frame: approximately 60 minutes
description: Outcome not included in a priori interim analysis plan as per the protocol. This exploratory endpoint will be measured by recording initial resting pressures (in cmH20) using the updated e۰Sense® catheters while each subject is positioned in a sitting, standing and supine position, if patient mobility allows. Resting pressures will be recorded on each subjects' CRF 1 during their urodynamics visit.
measure: Assess Resting Pressure at Different Filling and Emptying Volumes
time frame: approximately 60 minutes
description: Outcome not included in a priori interim analysis plan as per the protocol. This exploratory endpoint will be measured by recording resting pressures (in cmH20) using the updated e۰Sense® catheters during various points of the UDS test as applicable (every 100 mL of filling, MCC, and post-void) at the recorded patient position (sitting, standing, or supine). Patients are to remain in the same position throughout, however supplemental positions can be used (e.g. performing provocative manoeuvres). Resting pressures and patient position will be recorded on each subjects' CRF 1 during their urodynamics visit.
arm group label: Subjects Indicated for a UDS study
arm group type: Experimental
description: The investigational device, i.e. the eSense catheter will be used in all the subjects to assess primary and exploratory objectives. It is a single arm study with no comparative, placebo, sham or control arm.
intervention type: Device
intervention name: eSense 7fr Single Sensor Bladder Catheter
description: Urinary and abdominal catheters inserted in to the body to measure pressure for urodynamics.
arm group label: Subjects Indicated for a UDS study
other name: eSense 7Fr Abdominal Catheters
other name: eSense 7Fr Dual Sensor Urethral Catheters
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Ruth Kirschner-Hermanns, MD
role: Principal Investigator
affiliation: Rehabilitationszentrum Godeshöhe
facility: 
country: Germany
citation: Fleiss, J.L., Levin, B., & Cho Paik, M. (2003). Statistical Methods for Rates and Proportions (3rd ed.). New York, NY: Wiley
responsible party type: Sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 