<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/NCT02989818</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201600246</org_study_id>
    <nct_id>NCT02989818</nct_id>
  </id_info>
  <brief_title>Multi-center Evaluation of the Clinical Utility of ESD in the Western Population</brief_title>
  <official_title>Multi-center Prospective Evaluation of the Clinical Utility of Endoscopic Submucosal Dissection (ESD) in the Western Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this multi-center study is to prospectively document the clinical utility of ESD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multi-center prospective data recording study. All patients will receive standard medical&#xD;
      care and no experimental interventions will be performed.&#xD;
&#xD;
      All patients scheduled to undergo ESD at the University of Florida and participating centers&#xD;
      as medically indicated will be considered for the study. Patients in whom ESD is considered&#xD;
      as part of their standard medical care will be offered to participate in this study. The&#xD;
      physician performing the procedure will also discuss the study with the subjects. If the&#xD;
      patient agrees to participate, he or she will be given the informed consent form and allowed&#xD;
      enough time to read it. Opportunity to ask questions will be provided. If the patient agrees&#xD;
      to participate, he or she will sign the consent form and a copy will be provided. Data will&#xD;
      be prospectively recorded according to the data collection form. ESD will be performed as&#xD;
      medically indicated. The investigators from each respective center on this project will also&#xD;
      be in charge of the medical care of the patients enrolled in the study. Follow-up will be&#xD;
      carried out as medically indicated and no additional studies or clinic visits will be needed&#xD;
      specifically for the purpose of this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 2016</start_date>
  <completion_date type="Anticipated">January 2026</completion_date>
  <primary_completion_date type="Anticipated">January 2026</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of en-bloc resection</measure>
    <time_frame>3-4 hours</time_frame>
    <description>An Excision of the targeted lesion in a single specimen</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of R0 resection</measure>
    <time_frame>3-4 hours</time_frame>
    <description>when all vertical and horizontal margins are negative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of R1 resection</measure>
    <time_frame>3-4 hours</time_frame>
    <description>complete resection with no grossly visible lesion defined by endoscopist but microscopically positive horizontal and /or vertical margins</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Curative resection</measure>
    <time_frame>3-4 hours</time_frame>
    <description>this will have the following: R0 resection, Well to moderately differentiated histology, Absence of Lymphovascular invasion, Absence of budding, Absence of invasion beyond superficial submucosa</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Adverse events with ESD</measure>
    <time_frame>1 month</time_frame>
    <description>Early (&lt;48 hours) and late (&gt;48 hours) adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of complete remission of neoplasia</measure>
    <time_frame>1 month</time_frame>
    <description>Absence of a visible lesion and/or absence of the neoplastic lesion on biopsy specimens (histopathology) obtained from the ESD site on follow up evaluations</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Endoscopic Submucosal Dissection</condition>
  <arm_group>
    <arm_group_label>Lesion of the Gastrointestinal tract</arm_group_label>
    <description>Investigator will collect prospective data on the Endoscopic Submucosal dissection that is used as part of the subjects standard of care to remove the Gastrointestinal lesion</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Endoscopic Submucosal Dissection</intervention_name>
    <description>This intervention is part of the subjects standard of care and is a method to remove the Gastrointestinal lesion.</description>
    <arm_group_label>Lesion of the Gastrointestinal tract</arm_group_label>
    <other_name>ESD</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled to undergo ESD at the University of Florida and participating centers as&#xD;
        medically indicated and part of their standard of care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a. Age 18 years or older.&#xD;
&#xD;
          -  b. Scheduled to undergo ESD as part of their standard of care.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a. Any contraindication to performing endoscopy.&#xD;
&#xD;
          -  b. Participation in another research protocol that could interfere or influence the&#xD;
             outcome measures of the present study.&#xD;
&#xD;
          -  c. Patient is unable/unwilling to provide informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Draganov, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Peter Draganov, MD</last_name>
    <phone>352-273-9472</phone>
    <email>peter.draganov@medicine.ufl.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Draganov, MD</last_name>
      <phone>352-273-9472</phone>
      <email>peter.draganov@medicine.ufl.edu</email>
    </contact>
    <investigator>
      <last_name>Peter Draganov, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>June 9, 2023</last_update_submitted>
  <last_update_submitted_qc>June 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02989818
org study id: IRB201600246
nct id: NCT02989818
lead sponsor: 
has dmc: No
The aim of this multi-center study is to prospectively document the clinical utility of ESD.
Multi-center prospective data recording study. All patients will receive standard medical
      care and no experimental interventions will be performed.

      All patients scheduled to undergo ESD at the University of Florida and participating centers
      as medically indicated will be considered for the study. Patients in whom ESD is considered
      as part of their standard medical care will be offered to participate in this study. The
      physician performing the procedure will also discuss the study with the subjects. If the
      patient agrees to participate, he or she will be given the informed consent form and allowed
      enough time to read it. Opportunity to ask questions will be provided. If the patient agrees
      to participate, he or she will sign the consent form and a copy will be provided. Data will
      be prospectively recorded according to the data collection form. ESD will be performed as
      medically indicated. The investigators from each respective center on this project will also
      be in charge of the medical care of the patients enrolled in the study. Follow-up will be
      carried out as medically indicated and no additional studies or clinic visits will be needed
      specifically for the purpose of this study.
observational model: Cohort
time perspective: Prospective
measure: Rate of en-bloc resection
time frame: 3-4 hours
description: An Excision of the targeted lesion in a single specimen
measure: Rate of R0 resection
time frame: 3-4 hours
description: when all vertical and horizontal margins are negative
measure: Rate of R1 resection
time frame: 3-4 hours
description: complete resection with no grossly visible lesion defined by endoscopist but microscopically positive horizontal and /or vertical margins
measure: Curative resection
time frame: 3-4 hours
description: this will have the following: R0 resection, Well to moderately differentiated histology, Absence of Lymphovascular invasion, Absence of budding, Absence of invasion beyond superficial submucosa
measure: Rate of Adverse events with ESD
time frame: 1 month
description: Early (<48 hours) and late (>48 hours) adverse events defined based on previously established criteria by the American Society of Gastrointestinal Endoscopy (ASGE)
measure: Rate of complete remission of neoplasia
time frame: 1 month
description: Absence of a visible lesion and/or absence of the neoplastic lesion on biopsy specimens (histopathology) obtained from the ESD site on follow up evaluations
arm group label: Lesion of the Gastrointestinal tract
description: Investigator will collect prospective data on the Endoscopic Submucosal dissection that is used as part of the subjects standard of care to remove the Gastrointestinal lesion
intervention type: Other
intervention name: Endoscopic Submucosal Dissection
description: This intervention is part of the subjects standard of care and is a method to remove the Gastrointestinal lesion.
arm group label: Lesion of the Gastrointestinal tract
other name: ESD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Peter Draganov, MD
role: Principal Investigator
affiliation: University of Florida
last name: Peter Draganov, MD
phone: 352-273-9472
email: peter.draganov@medicine.ufl.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
sharing ipd: Undecided