<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/NCT03240679</url>
  </required_header>
  <id_info>
    <org_study_id>16-006909</org_study_id>
    <nct_id>NCT03240679</nct_id>
  </id_info>
  <brief_title>Endoscopic Mucosal Resection and Cellular Matrix</brief_title>
  <official_title>A Randomized Study of Biologic Scaffolds And Esophageal Healing Following Endoscopic Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done to test the usefulness of extracellular matrix (ECM) a thin sheet&#xD;
      placed over the site after endoscopic mucosal resection to promote healing of the esophagus.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulty obtaining investigational product and study support.&#xD;
  </why_stopped>
  <start_date type="Actual">March 22, 2017</start_date>
  <completion_date type="Actual">June 20, 2017</completion_date>
  <primary_completion_date type="Actual">June 20, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Pilot study 10 in each group</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Completeness of EMR Site Healing at Follow up Endoscopy</measure>
    <time_frame>approximately 3-4 months post EMR</time_frame>
    <description>Number of subjects to have complete endoscopic submucosal resection (EMR) site healing determined by the ability of the resection site to lift with saline injection during follow-up endoscopy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of Stricture Formation at Follow up Endoscopy</measure>
    <time_frame>approximately 3-4 months post EMR</time_frame>
    <description>Number of subjects to have symptomatic esophageal stricture formation requiring dilation, preventing dysphagia as determined by questionnaires, and mitigating formation of post-resection scarring as determined by blinded comparison of pre- and post-resection images (taken using white-light endoscopy and electron chromoendoscopy).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Barretts Esophagus With High Grade Dysplasia</condition>
  <condition>Barrett Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Endoscopic submucosal resection with Extracelluar Matrix</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endoscopic submucosal resection standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Acell MatriStem® Surgical Matrix</intervention_name>
    <description>Extracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time.</description>
    <arm_group_label>Endoscopic submucosal resection with Extracelluar Matrix</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Able to provide consent&#xD;
&#xD;
          -  Scheduled for standard of care endoscopy that may require initial EMR evaluation of&#xD;
             esophageal lesions&#xD;
&#xD;
          -  Histological evidence of intestinal metaplasia with dysplasia or intramucosal&#xD;
             carcinoma&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Prior esophageal EMR or ESD in the same region&#xD;
&#xD;
          -  Anyone unable to provide informed consent&#xD;
&#xD;
          -  Medical co-morbidities precluding EGD evaluation&#xD;
&#xD;
          -  History of chemoradiotherapy to the neck/esophagus&#xD;
&#xD;
          -  Unable to stop anticoagulation therapy (non-steroid anti-inflammatory medications are&#xD;
             permissible)&#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>Kenneth K Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>April 5, 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>January 10, 2023</results_first_submitted>
  <results_first_submitted_qc>January 10, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 6, 2023</results_first_posted>
  <last_update_submitted>January 10, 2023</last_update_submitted>
  <last_update_submitted_qc>January 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Kenneth K. Wang</investigator_full_name>
    <investigator_title>Pricipal Investigator</investigator_title>
  </responsible_party>
  <keyword>Barrett's esophagus</keyword>
  <keyword>Endoscopic Mucosal Resection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Barrett Esophagus</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>August 22, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03240679/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Endoscopic Submucosal Resection With Extracelluar Matrix</title>
          <description>Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.&#xD;
Acell MatriStem® Surgical Matrix: Extracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time.</description>
        </group>
        <group group_id="P2">
          <title>Endoscopic Submucosal Resection Standard of Care</title>
          <description>Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Endoscopic Submucosal Resection With Extracelluar Matrix</title>
          <description>Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.&#xD;
Acell MatriStem® Surgical Matrix: Extracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time.</description>
        </group>
        <group group_id="B2">
          <title>Endoscopic Submucosal Resection Standard of Care</title>
          <description>Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="3"/>
          </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="1"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" 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="1"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </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 group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </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>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Completeness of EMR Site Healing at Follow up Endoscopy</title>
        <description>Number of subjects to have complete endoscopic submucosal resection (EMR) site healing determined by the ability of the resection site to lift with saline injection during follow-up endoscopy.</description>
        <time_frame>approximately 3-4 months post EMR</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Endoscopic Submucosal Resection With Extracelluar Matrix</title>
            <description>Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.&#xD;
Acell MatriStem® Surgical Matrix: Extracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time.</description>
          </group>
          <group group_id="O2">
            <title>Endoscopic Submucosal Resection Standard of Care</title>
            <description>Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Completeness of EMR Site Healing at Follow up Endoscopy</title>
          <description>Number of subjects to have complete endoscopic submucosal resection (EMR) site healing determined by the ability of the resection site to lift with saline injection during follow-up endoscopy.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Presence of Stricture Formation at Follow up Endoscopy</title>
        <description>Number of subjects to have symptomatic esophageal stricture formation requiring dilation, preventing dysphagia as determined by questionnaires, and mitigating formation of post-resection scarring as determined by blinded comparison of pre- and post-resection images (taken using white-light endoscopy and electron chromoendoscopy).</description>
        <time_frame>approximately 3-4 months post EMR</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Endoscopic Submucosal Resection With Extracelluar Matrix</title>
            <description>Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.&#xD;
Acell MatriStem® Surgical Matrix: Extracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time.</description>
          </group>
          <group group_id="O2">
            <title>Endoscopic Submucosal Resection Standard of Care</title>
            <description>Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Presence of Stricture Formation at Follow up Endoscopy</title>
          <description>Number of subjects to have symptomatic esophageal stricture formation requiring dilation, preventing dysphagia as determined by questionnaires, and mitigating formation of post-resection scarring as determined by blinded comparison of pre- and post-resection images (taken using white-light endoscopy and electron chromoendoscopy).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from baseline to end of study participation for a total of approximately 16 weeks on all participants.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Endoscopic Submucosal Resection With Extracelluar Matrix</title>
          <description>Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.&#xD;
Acell MatriStem® Surgical Matrix: Extracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time.</description>
        </group>
        <group group_id="E2">
          <title>Endoscopic Submucosal Resection Standard of Care</title>
          <description>Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.</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="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>
    <limitations_and_caveats>Study terminated due to difficulty of obtaining investigational product and study support. Only 3 subjects accrued into the study who underwent initial endoscopy with treatment and follow-up endoscopies approximately 3 months later.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Kenneth K. Wang</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-284-2691</phone>
      <email>wang.kenneth@mayo.edu</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/NCT03240679
org study id: 16-006909
nct id: NCT03240679
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This study is being done to test the usefulness of extracellular matrix (ECM) a thin sheet
      placed over the site after endoscopic mucosal resection to promote healing of the esophagus.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Pilot study 10 in each group
primary purpose: Prevention
masking: None (Open Label)
measure: Completeness of EMR Site Healing at Follow up Endoscopy
time frame: approximately 3-4 months post EMR
description: Number of subjects to have complete endoscopic submucosal resection (EMR) site healing determined by the ability of the resection site to lift with saline injection during follow-up endoscopy.
measure: Presence of Stricture Formation at Follow up Endoscopy
time frame: approximately 3-4 months post EMR
description: Number of subjects to have symptomatic esophageal stricture formation requiring dilation, preventing dysphagia as determined by questionnaires, and mitigating formation of post-resection scarring as determined by blinded comparison of pre- and post-resection images (taken using white-light endoscopy and electron chromoendoscopy).
arm group label: Endoscopic submucosal resection with Extracelluar Matrix
arm group type: Active Comparator
description: Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive extracellular matrix (ECM) to the defect site.
arm group label: Endoscopic submucosal resection standard of care
arm group type: No Intervention
description: Subjects with lesions that lift and are amenable to cap-assisted endoscopic submucosal resection (EMR) will receive standard of care.
intervention type: Device
intervention name: Acell MatriStem® Surgical Matrix
description: Extracellular matrix (ECM) product that is composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling to facilitate constructive healing following endoscopic submucosal resection (EMR). Covers the defect site following mucosal resection using endoscopy clips or X-tac. The device will remain attached to the esophagus and integrate with native tissue over time.
arm group label: Endoscopic submucosal resection with Extracelluar Matrix
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kenneth K Wang
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Kenneth K. Wang
investigator title: Pricipal Investigator
mesh term: Barrett Esophagus
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study terminated due to difficulty of obtaining investigational product and study support. Only 3 subjects accrued into the study who underwent initial endoscopy with treatment and follow-up endoscopies approximately 3 months later.
point of contact: 