<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/NCT02196519</url>
  </required_header>
  <id_info>
    <org_study_id>PRO-106-0028</org_study_id>
    <nct_id>NCT02196519</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Cohera Sylys Surgical Sealant as an Adjunct to Standard Bowel Anastomosis Closure</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cohera Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cohera Medical, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A first in human study evaluating the safety of Sylys Surgical Sealant in protecting the&#xD;
      anastomotic junction created during a stoma reversal procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Adverse Events</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Stoma Reversal Procedure</condition>
  <arm_group>
    <arm_group_label>Test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All test arm subjects received Sylys Surgical sealant around anastomotic junction after closure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sylys Surgical Sealant</intervention_name>
    <arm_group_label>Test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be at least 18 years of age&#xD;
&#xD;
          -  Be in good general health in the opinion of the investigator with no conditions that&#xD;
             would significantly impact wound healing as determined by medical history and review&#xD;
             of recent concomitant medications&#xD;
&#xD;
          -  Be scheduled for an ileostomy reversal procedure&#xD;
&#xD;
          -  Be willing to follow instructions for incision care&#xD;
&#xD;
          -  Agree to return for all follow-up evaluations specified in this protocol&#xD;
&#xD;
          -  Sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anesthesia risk judged to be higher than ASA2&#xD;
&#xD;
          -  Have severe co-morbid conditions that pose a high risk for surgery and adequate&#xD;
             recovery (e.g., heart disease)&#xD;
&#xD;
          -  Any condition involving compromised immune system&#xD;
&#xD;
          -  Any condition known to effect wound healing, such as collagen vascular disease&#xD;
&#xD;
          -  Known blood clotting disorder&#xD;
&#xD;
          -  Be receiving antibiotic therapy for pre-existing condition or infection&#xD;
&#xD;
          -  Concurrent use of fibrin sealants or other anastomosis care devices&#xD;
&#xD;
          -  Be currently taking systemic steroids or immunosuppressive agents&#xD;
&#xD;
          -  Have known or suspected allergy or sensitivity to any test materials or reagents&#xD;
&#xD;
          -  Be participating in any current clinical trial or have participated in any clinical&#xD;
             trial within 30 days of enrollment in this study&#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>W Bemelman</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>E Consten</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meander Medical Center- Amersfoort</affiliation>
  </overall_official>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 18, 2014</last_update_submitted>
  <last_update_submitted_qc>July 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02196519
org study id: PRO-106-0028
nct id: NCT02196519
lead sponsor: 
has dmc: Yes
A first in human study evaluating the safety of Sylys Surgical Sealant in protecting the
      anastomotic junction created during a stoma reversal procedure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Adverse Events
time frame: 30 days
arm group label: Test
arm group type: Experimental
description: All test arm subjects received Sylys Surgical sealant around anastomotic junction after closure.
intervention type: Device
intervention name: Sylys Surgical Sealant
arm group label: Test
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: W Bemelman
role: Principal Investigator
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
last name: E Consten
role: Principal Investigator
affiliation: Meander Medical Center- Amersfoort
responsible party type: Sponsor