<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/NCT03241368</url>
  </required_header>
  <id_info>
    <org_study_id>COVSBCC0549</org_study_id>
    <nct_id>NCT03241368</nct_id>
  </id_info>
  <brief_title>Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease.</brief_title>
  <acronym>BLINK</acronym>
  <official_title>Multicenter, Prospective, Study Comparing PillCam® Crohn's Capsule Endoscopy (CE) to Ileocolonoscopy (IC) Plus MRE for Detection of Active Crohn's Disease (CD) in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic - MITG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic - MITG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC)&#xD;
      plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with&#xD;
      known CD and mucosal disease.&#xD;
&#xD;
      The primary objective of the study is to assess the accuracy of CE versus IC plus MRE for&#xD;
      detecting active CD, by visualizing the small bowel and colon in subjects with known CD and&#xD;
      mucosal disease.&#xD;
&#xD;
      There will be assessment of mucosal disease activity at baseline. Patient satisfaction&#xD;
      questionnaire will be completed at baseline.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, prospective, study, evaluating the efficacy of CE versus IC plus MRE&#xD;
      for detecting active Crohn's Disease (CD) in the small bowel and colon in subjects with known&#xD;
      CD and mucosal disease.&#xD;
&#xD;
      A screening visit will be performed within 30 days prior to baseline procedures to assess&#xD;
      pre-procedure eligibility. At this visit the following assessments will be performed:&#xD;
      Informed Consent, Inclusion/Exclusion Criteria, Demographics, Montreal Classification,&#xD;
      Medical History, Previous GI procedures, Surgical history, Laboratory tests and pregnancy&#xD;
      tests.&#xD;
&#xD;
      At baseline, subjects with known CD on routine evaluation (e.g. history, physical exams,&#xD;
      labs) and a recent history of mucosal disease (within the last 2 years and diagnosis based on&#xD;
      radiologic, endoscopic, or histologic findings) OR subjects with known CD and active disease&#xD;
      based on clinical judgment based on symptoms, laboratory data or other clinical information&#xD;
      will undergo Magnetic Resonance Enterography (MRE), Capsule Endoscopy (CE) and&#xD;
      Ileocolonoscopy (IC), to assess presence or absence of CD across the small and large bowel.&#xD;
      Also, at baseline the following assessments will take place: Laboratory tests, Pregnancy&#xD;
      test, Concomitant medications, Patient satisfaction questionnaire and Adverse Events (AE).&#xD;
&#xD;
      Subjects will be exited from the study once all Baseline Procedures have been completed and&#xD;
      AEs resolved.&#xD;
&#xD;
      All CE videos, IC videos and MRE images will be evaluated by central readers.&#xD;
&#xD;
      The planned number of subjects is 352. Subjects will be enrolled at up to 40 sites in the&#xD;
      United States, Israel, and Austria. Study duration is expected to be up to approximately 1.5&#xD;
      years. The expected duration of each subject's participation is approximately 1 month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 21, 2017</start_date>
  <completion_date type="Actual">June 20, 2019</completion_date>
  <primary_completion_date type="Actual">June 20, 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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of CE Versus IC Plus MRE for Detecting Active Crohn's Disease (CD), by Visualizing the Small Bowel and Colon in Subjects With Know CD and Mucosal Disease.</measure>
    <time_frame>Baseline</time_frame>
    <description>Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists.&#xD;
Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specificity, Negative Predictive Value, and Positive Predictive Value for Active CD in the Small Bowel and Colon by CE as Compared to IC Plus MRE.</measure>
    <time_frame>Baseline</time_frame>
    <description>Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists.&#xD;
Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE</measure>
    <time_frame>Baseline</time_frame>
    <description>Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists.&#xD;
Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>After completion of final procedure, either the same day or by the next business day following procedure completion.</time_frame>
    <description>Patient preference of which procedure they preferred (CE, IC or MRE plus IC)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">187</enrollment>
  <condition>Crohn Disease</condition>
  <arm_group>
    <arm_group_label>MRE, Patency Capsule (if needed), CE, and IC</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single-arm study, which includes MRE procedure, Patency Capsule Procedure (if needed), PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Capsule Endoscopy</intervention_name>
    <description>At baseline subject will under the PillCam Crohn's Capsule Procedure</description>
    <arm_group_label>MRE, Patency Capsule (if needed), CE, and IC</arm_group_label>
    <other_name>PillCam Crohn's® Capsule</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has provided informed consent.&#xD;
&#xD;
          -  Subject is ≥ 18 years of age&#xD;
&#xD;
          -  Subject is willing and able to comply with all aspects of treatment and evaluation&#xD;
             schedule.&#xD;
&#xD;
          -  Subject has known CD and a recent history (within last 2 years) of mucosal disease&#xD;
             (based on radiologic, endoscopic, or histologic evidence) OR known CD and active&#xD;
             disease, based on clinical judgment based on symptoms, laboratory data or other&#xD;
             clinical information.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has indeterminate, ulcerative, antibiotic-associated colitis.&#xD;
&#xD;
          -  Subject has stool positive for ova and parasite and for Clostridium difficile toxins&#xD;
             within 3 months prior to enrollment.&#xD;
&#xD;
          -  Subject with other known infectious cause of abdominal symptoms.&#xD;
&#xD;
          -  Subject with clinical evidence of renal disease with the past 6 months, defined as&#xD;
             estimated glomerular filtration rate (GFR) outside the normal reference range.&#xD;
&#xD;
          -  Subject with known history of intestinal obstruction or current obstructive symptoms,&#xD;
             such as severe abdominal pain with accompanying nausea or vomiting, based on&#xD;
             investigator judgment.&#xD;
&#xD;
          -  Subject with a diagnosis of gastroparesis or small bowel or large bowel dysmotility.&#xD;
&#xD;
          -  Subject with suspected or known bowel obstruction, stricture (defined as unequivocal&#xD;
             proximal upstream dilation equal ≥ 2.5 cm), or fistula.&#xD;
&#xD;
          -  Subject has used non-steroidal anti-inflammatory drugs including aspirin, two times&#xD;
             per week, during the 4 weeks preceding enrollment. Low dose aspirin regimens (≤ 100 mg&#xD;
             daily) are acceptable and not exclusionary.&#xD;
&#xD;
          -  Subject suffers from any condition, such as swallowing problems, that precludes&#xD;
             compliance with study and/or device instructions.&#xD;
&#xD;
          -  Subject with cardiac pacemaker or other implanted electromedical device.&#xD;
&#xD;
          -  Subject has an allergy or other known contraindication to the medications used in the&#xD;
             study.&#xD;
&#xD;
          -  Subject is pregnant (documented by a positive pregnancy test) or is actively&#xD;
             breast-feeding.&#xD;
&#xD;
          -  Subject is considered to be a part of a vulnerable population (eg. prisoners or those&#xD;
             without sufficient mental capacity).&#xD;
&#xD;
          -  Subject has a known contraindication to MRE or IC.&#xD;
&#xD;
          -  Subject has participated in a drug or device research study within 30 days of&#xD;
             enrollment that may interfere with the subject's safety or ability to participate in&#xD;
             the study.&#xD;
&#xD;
          -  Subject has any medical condition that would make it unsafe for them to participate,&#xD;
             per Investigator's discretion&#xD;
&#xD;
          -  Subject with ileostomy or colostomy, history of total or subtotal colectomy (including&#xD;
             those with ileosigmoidostomy, and ileorectostomy)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Bruining, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of South Alabama</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36688</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic (Scottsdale, AZ)</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Encore Borland Groover Clinical Research</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Center for Digestive Healthcare</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University - Chicago</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indianapolis Gastroenterology Research Foundation</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louisiana State University Health Science Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts Memorial Medical Center</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic (Rochester, MN)</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantic Health (Morristown)</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07962</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asheville Gastroenterology Associates, PA</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Disease Specialists Inc.</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterology Associates of Tidewater</name>
      <address>
        <city>Chesapeake</city>
        <state>Virginia</state>
        <zip>23320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carilion Clinic</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Gastroenterology Institute</name>
      <address>
        <city>Suffolk</city>
        <state>Virginia</state>
        <zip>23434</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allgemeines Krankenhaus - Universitatskliniken Wein</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Tel Hashomer</city>
        <state>Ramat Gan</state>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Israel</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <results_first_submitted>May 11, 2020</results_first_submitted>
  <results_first_submitted_qc>May 28, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 9, 2020</results_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Irritable Bowel Disease</keyword>
  <keyword>IBD</keyword>
  <keyword>Mucosal Disease</keyword>
  <keyword>Crohn's</keyword>
  <keyword>Inflammatory Bowel Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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>November 16, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03241368/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>187 subjects signed consent. Per the protocol, a subject was not considered &quot;enrolled&quot; until consent was signed and subject met inclusion/exclusion criteria. Of the 187 who signed consent, 158 were considered &quot;enrolled&quot; per the protocol. 29 were &quot;screen failures&quot;, i.e. they signed informed consent, but ended up failing inclusion/exclusion.</recruitment_details>
      <pre_assignment_details>Of the 187 subjects who signed informed consent, 29 failed inclusion/exclusion criteria and were exited from the study. Criteria included labs, which caused some subjects to wash out at this early phase. This left us with 158 subjects. For various reasons, 39 additional subjects were exited prior to all imaging procedures being completed.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>MRE, Patency Capsule (if Needed), CE, and IC</title>
          <description>Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures.&#xD;
If MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency not confirmed by MRE or patency capsule, subject is discontinued from study.&#xD;
Subjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final polyethylene glycol (PEG) ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first).&#xD;
After CE procedure (either same or following day), subject will undergo IC. If IC is done the following day, subject will stay on clear liquid diet (or NPO (nothing by mouth), per physician discretion).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="158"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="119"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>MRE Stricture or Patency Capsule Failure</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Per-protocol analysis set, included subjects who underwent MRE, CE, and IC (and could be evaluated for CD activity) with no major protocol deviations (violations that may have significant impact on outcomes) and did not meet the following: subject withdraw; capsule remained in stomach or small bowel for entire procedure; system technical failure</population>
      <group_list>
        <group group_id="B1">
          <title>MRE, Patency Capsule (if Needed), CE, and IC</title>
          <description>Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures.&#xD;
If MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency cannot be confirmed through MRE or patency capsule will be discontinued from the study.&#xD;
Subjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final PEG ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first).&#xD;
After CE procedure (either same or following day), subject will undergo IC. If the IC is done the following day, subject will stay on clear liquid diet (or NPO, per physician's discretion for sedation).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="99"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</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="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </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>Number</param>
          <class_list>
            <class>
              <title>Austria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Israel</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m²</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.82" spread="7.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Accuracy of CE Versus IC Plus MRE for Detecting Active Crohn's Disease (CD), by Visualizing the Small Bowel and Colon in Subjects With Know CD and Mucosal Disease.</title>
        <description>Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists.&#xD;
Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score</description>
        <time_frame>Baseline</time_frame>
        <population>Per-protocol analysis set, includes subjects who underwent MRE, CE, and IC (and could be evaluated for CD activity) who had no major deviations (violations that may have significant impact on outcomes) and did not meet following criteria:&#xD;
Subject withdraws&#xD;
Capsule remained in stomach or small bowel for entire procedure&#xD;
Technical failure</population>
        <group_list>
          <group group_id="O1">
            <title>MRE, Patency Capsule (if Needed), CE, and IC</title>
            <description>Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures.&#xD;
If MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency cannot be confirmed through MRE or patency capsule will be discontinued from the study.&#xD;
Subjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final PEG ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first).&#xD;
After CE procedure (either same or following day), subject will undergo IC. If the IC is done the following day, subject will stay on clear liquid diet (or NPO, per physician's discretion for sedation).</description>
          </group>
        </group_list>
        <measure>
          <title>Accuracy of CE Versus IC Plus MRE for Detecting Active Crohn's Disease (CD), by Visualizing the Small Bowel and Colon in Subjects With Know CD and Mucosal Disease.</title>
          <description>Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists.&#xD;
Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score</description>
          <population>Per-protocol analysis set, includes subjects who underwent MRE, CE, and IC (and could be evaluated for CD activity) who had no major deviations (violations that may have significant impact on outcomes) and did not meet following criteria:&#xD;
Subject withdraws&#xD;
Capsule remained in stomach or small bowel for entire procedure&#xD;
Technical failure</population>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sensitivity CE Overall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94" lower_limit="86" upper_limit="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensitivity MRE + IC Overall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="95" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specificity CE Overall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74" lower_limit="55" upper_limit="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specificity MRE + IC Overall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22" lower_limit="10" upper_limit="41"/>
                  </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>This was a 1-arm, non-powered study. Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) was estimated for each treatment group, along with the 95% confidence interval. The difference between treatment groups in Sensitivity and Specificity was compared.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Comparative - This purpose of this study is to evaluate performance of the PillCam Crohn's capsule [referred to as capsule endoscopy (CE)] as compared to IC with MRE.</non_inferiority_desc>
            <p_value>0.125</p_value>
            <method>McNemar</method>
            <method_desc>Exact McNemar's test</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Specificity, Negative Predictive Value, and Positive Predictive Value for Active CD in the Small Bowel and Colon by CE as Compared to IC Plus MRE.</title>
        <description>Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists.&#xD;
Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MRE, Patency Capsule (if Needed), CE, and IC</title>
            <description>Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures.&#xD;
If MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency cannot be confirmed through MRE or patency capsule will be discontinued from the study.&#xD;
Subjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final PEG ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first).&#xD;
After CE procedure (either same or following day), subject will undergo IC. If the IC is done the following day, subject will stay on clear liquid diet (or NPO, per physician's discretion for sedation).</description>
          </group>
        </group_list>
        <measure>
          <title>Specificity, Negative Predictive Value, and Positive Predictive Value for Active CD in the Small Bowel and Colon by CE as Compared to IC Plus MRE.</title>
          <description>Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists.&#xD;
Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score</description>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Specificity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74" lower_limit="55" upper_limit="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative Predictive Value (NPV)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83" lower_limit="64" upper_limit="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive Predictive Value (PPV)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91" lower_limit="82" upper_limit="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE</title>
        <description>Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists.&#xD;
Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MRE, Patency Capsule (if Needed), CE, and IC</title>
            <description>Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures.&#xD;
If MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency cannot be confirmed through MRE or patency capsule will be discontinued from the study.&#xD;
Subjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final PEG ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first).&#xD;
After CE procedure (either same or following day), subject will undergo IC. If the IC is done the following day, subject will stay on clear liquid diet (or NPO, per physician's discretion for sedation).</description>
          </group>
        </group_list>
        <measure>
          <title>Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE</title>
          <description>Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists.&#xD;
Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score</description>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sensitivity CE Proximal Small Bowel (PSB)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97" lower_limit="82" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensitivity MRE PSB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71" lower_limit="53" upper_limit="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specificity CE PSB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87" lower_limit="76" upper_limit="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specificity MRE PSB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66" lower_limit="54" upper_limit="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NPV CE PSB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98" lower_limit="90" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NPV MRE PSB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83" lower_limit="71" upper_limit="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PPV CE PSB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77" lower_limit="62" upper_limit="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PPV MRE PSB</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49" lower_limit="35" upper_limit="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensitivity CE Terminal ilium (TI)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94" lower_limit="84" upper_limit="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensitivity MRE + IC TI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98" lower_limit="89" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specificity CE TI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82" lower_limit="66" upper_limit="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specificity MRE + IC TI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37" lower_limit="23" upper_limit="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NPV CE TI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91" lower_limit="76" upper_limit="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NPV MRE + IC TI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93" lower_limit="68" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PPV CE TI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88" lower_limit="76" upper_limit="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PPV MRE + IC TI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68" lower_limit="57" upper_limit="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensitivity CE Colon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83" lower_limit="62" upper_limit="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sensitivity IC Colon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91" lower_limit="72" upper_limit="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specificity CE Colon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88" lower_limit="77" upper_limit="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specificity IC Colon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89" lower_limit="79" upper_limit="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NPV CE Colon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93" lower_limit="84" upper_limit="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NPV IC Colon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97" lower_limit="88" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PPV CE Colon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70" lower_limit="51" upper_limit="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PPV IC Colon</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" lower_limit="56" upper_limit="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction</title>
        <description>Patient preference of which procedure they preferred (CE, IC or MRE plus IC)</description>
        <time_frame>After completion of final procedure, either the same day or by the next business day following procedure completion.</time_frame>
        <population>Subjects who completed the satisfaction questionnaire and underwent all 3 procedures MRE, CE, and IC and could be evaluated for overall active CD at baseline (i.e., a modified intent-to-treat (mITT).&#xD;
population).</population>
        <group_list>
          <group group_id="O1">
            <title>MRE, Patency Capsule (if Needed), CE, and IC</title>
            <description>Single-arm study, which includes MRE procedure, Patency Capsule Procedure (if needed), PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure.&#xD;
Capsule Endoscopy: At baseline subject will under the PillCam Crohn's Capsule Procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Patient preference of which procedure they preferred (CE, IC or MRE plus IC)</description>
          <population>Subjects who completed the satisfaction questionnaire and underwent all 3 procedures MRE, CE, and IC and could be evaluated for overall active CD at baseline (i.e., a modified intent-to-treat (mITT).&#xD;
population).</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="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Preferred PillCam CE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Preferred IC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Preferred MRE + IC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>MRE, Patency Capsule (if Needed), CE, and IC</title>
          <description>Single-arm study, which includes MRE procedure, Patency Capsule Procedure (if needed), PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure.&#xD;
Capsule Endoscopy: At baseline subject will under the PillCam Crohn's Capsule Procedure</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>ISO 14155:2011</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="119"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Crohn's Disease</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Complication of device removal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Serum sickness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>ISO 14155:2011</default_vocab>
        <default_assessment>Non-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="11" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Infusion site extravasation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Oesophageal candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Staphylococcal skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Emotional distress</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="119"/>
              </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>Amanda Wenisch, Clinical Resaerch Coordinator / Study Manager</name_or_title>
      <organization>Medtronic GIH</organization>
      <phone>1-206-225-4025</phone>
      <email>amanda.m.wenisch@medtronic.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/NCT03241368
org study id: COVSBCC0549
nct id: NCT03241368
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC)
      plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with
      known CD and mucosal disease.

      The primary objective of the study is to assess the accuracy of CE versus IC plus MRE for
      detecting active CD, by visualizing the small bowel and colon in subjects with known CD and
      mucosal disease.

      There will be assessment of mucosal disease activity at baseline. Patient satisfaction
      questionnaire will be completed at baseline.
This is a multicenter, prospective, study, evaluating the efficacy of CE versus IC plus MRE
      for detecting active Crohn's Disease (CD) in the small bowel and colon in subjects with known
      CD and mucosal disease.

      A screening visit will be performed within 30 days prior to baseline procedures to assess
      pre-procedure eligibility. At this visit the following assessments will be performed:
      Informed Consent, Inclusion/Exclusion Criteria, Demographics, Montreal Classification,
      Medical History, Previous GI procedures, Surgical history, Laboratory tests and pregnancy
      tests.

      At baseline, subjects with known CD on routine evaluation (e.g. history, physical exams,
      labs) and a recent history of mucosal disease (within the last 2 years and diagnosis based on
      radiologic, endoscopic, or histologic findings) OR subjects with known CD and active disease
      based on clinical judgment based on symptoms, laboratory data or other clinical information
      will undergo Magnetic Resonance Enterography (MRE), Capsule Endoscopy (CE) and
      Ileocolonoscopy (IC), to assess presence or absence of CD across the small and large bowel.
      Also, at baseline the following assessments will take place: Laboratory tests, Pregnancy
      test, Concomitant medications, Patient satisfaction questionnaire and Adverse Events (AE).

      Subjects will be exited from the study once all Baseline Procedures have been completed and
      AEs resolved.

      All CE videos, IC videos and MRE images will be evaluated by central readers.

      The planned number of subjects is 352. Subjects will be enrolled at up to 40 sites in the
      United States, Israel, and Austria. Study duration is expected to be up to approximately 1.5
      years. The expected duration of each subject's participation is approximately 1 month.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Accuracy of CE Versus IC Plus MRE for Detecting Active Crohn's Disease (CD), by Visualizing the Small Bowel and Colon in Subjects With Know CD and Mucosal Disease.
time frame: Baseline
description: Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists.
Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score
measure: Specificity, Negative Predictive Value, and Positive Predictive Value for Active CD in the Small Bowel and Colon by CE as Compared to IC Plus MRE.
time frame: Baseline
description: Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists.
Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score
measure: Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE
time frame: Baseline
description: Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists.
Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score
measure: Patient Satisfaction
time frame: After completion of final procedure, either the same day or by the next business day following procedure completion.
description: Patient preference of which procedure they preferred (CE, IC or MRE plus IC)
arm group label: MRE, Patency Capsule (if needed), CE, and IC
arm group type: Other
description: Single-arm study, which includes MRE procedure, Patency Capsule Procedure (if needed), PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure.
intervention type: Device
intervention name: Capsule Endoscopy
description: At baseline subject will under the PillCam Crohn's Capsule Procedure
arm group label: MRE, Patency Capsule (if needed), CE, and IC
other name: PillCam Crohn's® Capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Bruining, MD
role: Principal Investigator
affiliation: Mayo
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country: Austria
country: Israel
country: United States
responsible party type: Sponsor
mesh term: Crohn Disease
sharing ipd: No
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certain agreements: 
point of contact: 