<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/NCT03251040</url>
  </required_header>
  <id_info>
    <org_study_id>2015.458</org_study_id>
    <nct_id>NCT03251040</nct_id>
  </id_info>
  <brief_title>Fibrin Sealant in Esophageal Surgery</brief_title>
  <acronym>SEAL</acronym>
  <official_title>Autologous Activated Fibrin Sealant for the Esophageal Anastomosis, a Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amsterdam UMC, location VUmc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amsterdam UMC, location VUmc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anastomotic leakage remains a major complication after esophageal surgery. Amongst other&#xD;
      preventive measures, fibrin sealant is a promising adjunct to conventional anastomotic&#xD;
      techniques. The investigators aimed to investigate feasibility of additional sealing by means&#xD;
      of autologous fibrin sealant of the esophageal anastomosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2015</start_date>
  <completion_date type="Actual">May 1, 2017</completion_date>
  <primary_completion_date type="Actual">April 1, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Pilot study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anastomotic leakage</measure>
    <time_frame>30-day morbidity</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Anastomotic Leak</condition>
  <arm_group>
    <arm_group_label>Fibrin sealant</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single arm pilot study</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Autologous activated fibrin sealant</intervention_name>
    <description>Application of fibrin sealant</description>
    <arm_group_label>Fibrin sealant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 - 90 years&#xD;
&#xD;
          -  Scheduled to undergo elective minimal invasive esophageal surgery with thoracic or&#xD;
             cervical anastomosis (i.e. Ivor Lewis, Orringer or McKeown esophagectomy).&#xD;
&#xD;
          -  physical status (American Society of Anesthesiologists) of 3 or lower&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other malignancies&#xD;
&#xD;
          -  Previous esophageal surgery were excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Freek Daams, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Amsterdam UMC, location VUmc</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>August 18, 2017</last_update_submitted>
  <last_update_submitted_qc>August 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Amsterdam UMC, location VUmc</investigator_affiliation>
    <investigator_full_name>Victor Plat</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Esophagogastric anastomosis</keyword>
  <keyword>Fibrin sealant</keyword>
  <keyword>Sealing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anastomotic Leak</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibrin Tissue Adhesive</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03251040
org study id: 2015.458
nct id: NCT03251040
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Anastomotic leakage remains a major complication after esophageal surgery. Amongst other
      preventive measures, fibrin sealant is a promising adjunct to conventional anastomotic
      techniques. The investigators aimed to investigate feasibility of additional sealing by means
      of autologous fibrin sealant of the esophageal anastomosis.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Pilot study
primary purpose: Prevention
masking: None (Open Label)
measure: Anastomotic leakage
time frame: 30-day morbidity
arm group label: Fibrin sealant
arm group type: Other
description: Single arm pilot study
intervention type: Device
intervention name: Autologous activated fibrin sealant
description: Application of fibrin sealant
arm group label: Fibrin sealant
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Freek Daams, MD PhD
role: Study Director
affiliation: Amsterdam UMC, location VUmc
responsible party type: Principal Investigator
investigator affiliation: Amsterdam UMC, location VUmc
investigator full name: Victor Plat
investigator title: Principal investigator
mesh term: Anastomotic Leak
mesh term: Fibrin Tissue Adhesive
sharing ipd: No