<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/NCT03026075</url>
  </required_header>
  <id_info>
    <org_study_id>CL00016</org_study_id>
    <nct_id>NCT03026075</nct_id>
  </id_info>
  <brief_title>Evaluation of the Performance of the Motus Cleansing System (MCS)</brief_title>
  <acronym>MCS</acronym>
  <official_title>Evaluation of the Performance of the Motus Cleansing System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Motus GI Medical Technologies Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Motus GI Medical Technologies Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is multi-center study ,planned as a single arm, open trial, aimed at evaluating the&#xD;
      performance and safety of a colon cleansing device during a colonoscopy procedure in a poorly&#xD;
      prepared colons.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total of 47 subjects are planned to be enrolled at 3 clinical sites (1 in Germany and 2 in&#xD;
      the Netherlands).&#xD;
&#xD;
      Subjects who meet the eligibility criteria will be screened for study participation at a&#xD;
      baseline visit(visit 1). Subject who is eligible to the study will required to follow a&#xD;
      specific reduced preparation instruction starting 2 days prior to the colonoscopy with the&#xD;
      Motus Cleansing System (MCS) procedure.&#xD;
&#xD;
      Following the procedure a telephone follow-up will be conducted at 48 hours (± 24 hours) and&#xD;
      14 days (± 3 days) post MCS procedure to assess patient well-being and capture any Adverse&#xD;
      Events (AE).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 22, 2016</start_date>
  <completion_date type="Actual">May 31, 2017</completion_date>
  <primary_completion_date type="Actual">May 31, 2017</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Performance of MCS in Cleansing a Poorly Prepared Colon.</measure>
    <time_frame>Up to 2 hours</time_frame>
    <description>The rate of adequate cleansing level per subject will be evaluated by the Boston Bowel Preparation (BBPS) scoring index before and post the cleansing operation.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>CRC</condition>
  <arm_group>
    <arm_group_label>Colonoscopy with MCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard colonoscopy procedure with Motus Cleansing System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Motus Cleansing System (MCS)</intervention_name>
    <description>The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter &amp; fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.</description>
    <arm_group_label>Colonoscopy with MCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects being considered for diagnostic, screening or surveillance colonoscopy&#xD;
&#xD;
          2. Subjects in the age range of 18-75 years inclusive&#xD;
&#xD;
          3. Subjects with BodyMass Index (BMI) within the range of 18.5-35 inclusive&#xD;
&#xD;
          4. Subject has signed the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with known Inflammatory Bowel Disease&#xD;
&#xD;
          2. Subjects with known diverticulitis disease or with prior incomplete colonoscopy due to&#xD;
             diverticular disease&#xD;
&#xD;
          3. Subjects with known or detected (during colonoscopy) bowel obstruction&#xD;
&#xD;
          4. History of prior surgery to colon and/or rectum&#xD;
&#xD;
          5. ASA≥IV&#xD;
&#xD;
          6. Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history)&#xD;
&#xD;
          7. Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical&#xD;
             history)&#xD;
&#xD;
          8. Subjects taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy&#xD;
&#xD;
          9. Subjects with known coagulation disorder (INR &gt;1.5).&#xD;
&#xD;
         10. Subjects treated with H2 receptor antagonists or proton pump inhibitors within the 72&#xD;
             hours prior to consuming the Bisacodyl&#xD;
&#xD;
         11. Subjects with active, ongoing lower GI bleeding with hemodynamic instability.&#xD;
&#xD;
         12. Subjects with known Mega Colon&#xD;
&#xD;
         13. Pregnancy (as stated by patient) or breast feeding&#xD;
&#xD;
         14. Subjects with altered mental status/inability to provide informed consent&#xD;
&#xD;
         15. Patients who have participated in another interventional clinical study in the last 2&#xD;
             months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ravit Peled</last_name>
    <role>Study Director</role>
    <affiliation>Motus GI Technologies Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UMC Of JOHANNES GUTENBERG-UNIVERSITY MAINZ</name>
      <address>
        <city>Mainz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Centre (UMC) Radboud Department of Gastroenterology and Hepatology</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus medical center</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <results_first_submitted>December 27, 2017</results_first_submitted>
  <results_first_submitted_qc>September 25, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 11, 2019</results_first_posted>
  <last_update_submitted>September 25, 2018</last_update_submitted>
  <last_update_submitted_qc>September 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <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>June 27, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/75/NCT03026075/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>patients indicated for screening/ surveillance or diagnosis colonoscopy enrolled at 3 clinical sites as follows:&#xD;
Radboud University Medical Center(UMC)- Netherlands-16 cases&#xD;
Erasmus Medical Center (MC)-Netherlands-16 cases&#xD;
Mainz University Medical Center(UMC)-Germany- 15 cases&#xD;
enrollment period : 20 December 2016 - 31 May 2017</recruitment_details>
      <pre_assignment_details>The patients had reduced preparation in order to mimic poor bowel cleansing. the study bowel preparation consisted of dietary restrictions (no dried fruit, seeds or nuts) starting 2 days prior to colonoscopy, a 24-hour clear liquid diet and a split dose of 20 mg Bisacodyl (10 mg in each dose).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Colonoscopy With MCS</title>
          <description>Standard colonoscopy procedure with Motus Cleansing System&#xD;
Motus Cleansing System (MCS): The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter &amp; fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Colonoscopy With MCS</title>
          <description>Standard colonoscopy procedure with Motus Cleansing System&#xD;
Motus Cleansing System (MCS): The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter &amp; fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="47"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56.9" spread="11.8"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnicity</title>
              <category_list>
                <category>
                  <title>White Non-Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.0" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Performance of MCS in Cleansing a Poorly Prepared Colon.</title>
        <description>The rate of adequate cleansing level per subject will be evaluated by the Boston Bowel Preparation (BBPS) scoring index before and post the cleansing operation.</description>
        <time_frame>Up to 2 hours</time_frame>
        <population>the bowel preparation level before and after the use of Motus Cleansing System was evaluated using the Boston Bowel Preparation Scale (BBPS) where patients consider to have adequate cleansing level if all 3 colon segments graded 2 or 3 ( good or excellent)</population>
        <group_list>
          <group group_id="O1">
            <title>Colonoscopy With MCS</title>
            <description>Standard colonoscopy procedure with Motus Cleansing System&#xD;
Motus Cleansing System (MCS): The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter &amp; fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.</description>
          </group>
        </group_list>
        <measure>
          <title>Performance of MCS in Cleansing a Poorly Prepared Colon.</title>
          <description>The rate of adequate cleansing level per subject will be evaluated by the Boston Bowel Preparation (BBPS) scoring index before and post the cleansing operation.</description>
          <population>the bowel preparation level before and after the use of Motus Cleansing System was evaluated using the Boston Bowel Preparation Scale (BBPS) where patients consider to have adequate cleansing level if all 3 colon segments graded 2 or 3 ( good or excellent)</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="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>adequate cleaning after the use of MCS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>adequate cleaning at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The primary objective of the study is to evaluate the effectiveness of MCS in cleansing a poorly prepared colon.&#xD;
A sample size of 47 patients is required as per a McNemar test to determine that the paired discordant proportions are significantly different under the followings assumptions:&#xD;
Probability of Type I Error (α) = 0.05, Power (1 - β) = 0.8 Proportion switching from + to - = 0, Proportion switching from - to + = 0.6 Potential of dropout 10% (i.e. 4 cases)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>McNemar</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Follow up was conducted immediately after the procedure before patient discharge and at 2-3 days and 14-16 days post procedure</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Colonoscopy With MCS</title>
          <description>Standard colonoscopy procedure with Motus Cleansing System&#xD;
Motus Cleansing System (MCS): The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter &amp; fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.</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="47"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="5" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bloating</sub_title>
                <description>abdominal discomfort and or stomach discomfort</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="47"/>
              </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>Ravit Peled -Director of Clinical Trial</name_or_title>
      <organization>Motus GI Medical Technologies Ltd.</organization>
      <phone>0733243823 ext 203</phone>
      <email>ravit@motusgi.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/NCT03026075
org study id: CL00016
nct id: NCT03026075
lead sponsor: 
has dmc: Yes
The study is multi-center study ,planned as a single arm, open trial, aimed at evaluating the
      performance and safety of a colon cleansing device during a colonoscopy procedure in a poorly
      prepared colons.
Total of 47 subjects are planned to be enrolled at 3 clinical sites (1 in Germany and 2 in
      the Netherlands).

      Subjects who meet the eligibility criteria will be screened for study participation at a
      baseline visit(visit 1). Subject who is eligible to the study will required to follow a
      specific reduced preparation instruction starting 2 days prior to the colonoscopy with the
      Motus Cleansing System (MCS) procedure.

      Following the procedure a telephone follow-up will be conducted at 48 hours (± 24 hours) and
      14 days (± 3 days) post MCS procedure to assess patient well-being and capture any Adverse
      Events (AE).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Performance of MCS in Cleansing a Poorly Prepared Colon.
time frame: Up to 2 hours
description: The rate of adequate cleansing level per subject will be evaluated by the Boston Bowel Preparation (BBPS) scoring index before and post the cleansing operation.
arm group label: Colonoscopy with MCS
arm group type: Experimental
description: Standard colonoscopy procedure with Motus Cleansing System
intervention type: Device
intervention name: Motus Cleansing System (MCS)
description: The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.
arm group label: Colonoscopy with MCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ravit Peled
role: Study Director
affiliation: Motus GI Technologies Ltd.
facility: 
facility: 
facility: 
country: Germany
country: Netherlands
responsible party type: Sponsor
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 