<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/NCT01706640</url>
  </required_header>
  <id_info>
    <org_study_id>MM/CTVS/2012/001</org_study_id>
    <nct_id>NCT01706640</nct_id>
  </id_info>
  <brief_title>An Open Label,Observational, Real Time Data Capturing of Usage &amp; Outcome of Coseal</brief_title>
  <official_title>An Open- Label,Multicentre, Observational, Prospective, Real-time Data Capturing of Usage, Outcome &amp; Physician Satisfaction of Coseal in Cardio- Vascular- Thoracic Operative and Re- Operative Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medanta, The Medicity, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medanta, The Medicity, India</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is Open- Label, Observational, Prospective, Real-time data capturing of Usage,&#xD;
      Outcome &amp; Physician satisfaction of Coseal in Cardio- Vascular-Thoracic Operative and Re-&#xD;
      Operative procedures.&#xD;
&#xD;
      Objective of this study is to assess current practice pattern and best practice sharing of&#xD;
      usage of Coseal by collecting data on (1) Sealing suture lines along arterial and venous&#xD;
      reconstruction(2) Patients undergoing cardiac surgery to prevent or reduce the incidence,&#xD;
      severity and extent of post surgical adhesion enforcement of suture lines in lung resection&#xD;
      procedures (3) From this data to document and generate a real life experience on the use of&#xD;
      Coseal in cardio vascular and thoracic surgery.&#xD;
&#xD;
      Number of expected patient enrollment is 750 from 20 participating sites.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives:&#xD;
&#xD;
        -  Assessing current practice pattern and best practice sharing of usage of Coseal as per&#xD;
           IFU by collecting data on oSealing suture lines along arterial and venous&#xD;
           reconstructions oPatients undergoing cardiac surgery to prevent or reduce the incidence,&#xD;
           severity and extent of post surgical adhesion enforcement of suture and staple lines in&#xD;
           lung resection procedures&#xD;
&#xD;
        -  From this data to document and generate a real life experience on the use of Coseal in&#xD;
           cardio vascular and thoracic surgery&#xD;
&#xD;
        -  To possibly create a guideline for usage of Sealant in routine practice in India&#xD;
&#xD;
        -  To study delivery methods and clinical impact in minimally invasive surgery like VATS&#xD;
           and robotic surgery&#xD;
&#xD;
      End points&#xD;
&#xD;
      Primary Endpoint&#xD;
&#xD;
        1. Cardio vascular sealing:&#xD;
&#xD;
           To report the effectiveness and safety of COSEAL in the control of anastomotic suture&#xD;
           line and needle hole suture bleeding during vascular reconstruction by checking the&#xD;
           incidence of immediate anastomotic sealing and the presence of persistent&#xD;
           intra-operative and postoperative bleeding average time to achieve hemostasis for a&#xD;
           single bleeding site after 60 s of clamping without manual compression In case of&#xD;
           sternotomy, Hemostasis time in mns, which is operative time comprised between the&#xD;
           removal of cardio-pulmonary bypass cannulae and the closure of the sternum.&#xD;
&#xD;
           Overall postoperative bleeding in mL/m² revision for bleeding Minor complications, major&#xD;
           complications, mortality&#xD;
&#xD;
        2. Efficacy of Coseal in prevention or reduction of adhesion in re-do surgeries for&#xD;
           patients with staged operations for congenital cardiac malformation re-operated on&#xD;
           during the follow-up period of the registry&#xD;
&#xD;
           Incidence of adhesions. location and extension of adhesion by measuring the percentage&#xD;
           of surface affected for each of the following regions: pericardial or retrosternal,&#xD;
           inferior or diaphragmatic region, right lateral or atrial region, region around the&#xD;
           great vessels, pulmonary surface.&#xD;
&#xD;
           Overall evaluation (dissection easy or difficult) Incidence of subjects free of&#xD;
           adhesions.&#xD;
&#xD;
           Severity (at each of these sites, the adhesions will be graded as follows:&#xD;
&#xD;
           absence of adhesion; 1: filmy and avascular; 2: dense and/or vascular; and 3: cohesive)&#xD;
&#xD;
        3. Air leak: incidence of immediate (at the time of closure) and prolonged post-operative&#xD;
           air leak, Use in redo surgery for air leak.&#xD;
&#xD;
      Secondary Endpoints&#xD;
&#xD;
        1. Cardiovascular (sealing and adhesion prevention):&#xD;
&#xD;
             1. Total operative time&#xD;
&#xD;
             2. Nature and duration of first operation&#xD;
&#xD;
             3. Nature and duration of redo operation, and time for dissection from sternotomy to&#xD;
                end of dissection for prevention of adhesions )&#xD;
&#xD;
             4. Length of intensive care stay&#xD;
&#xD;
             5. Length of hospital stay&#xD;
&#xD;
             6. Infection rate&#xD;
&#xD;
             7. Quality of wound healing&#xD;
&#xD;
             8. Quality of life (SF36)&#xD;
&#xD;
        2. Thoracic and Lung&#xD;
&#xD;
             1. Sealing the suture/ staple line on table Use of buttressing&#xD;
&#xD;
             2. Total operative time&#xD;
&#xD;
             3. Drain output&#xD;
&#xD;
             4. Drain duration&#xD;
&#xD;
             5. Length of hospital stay&#xD;
&#xD;
             6. Prolonged air leak (more than 5 days) (&gt;5 days is the new standard for prolonged&#xD;
                aire leak accepted in 2011 by the EU Soc of CVTS, see ref.)&#xD;
&#xD;
             7. Infection rate&#xD;
&#xD;
        3. In all cases,&#xD;
&#xD;
             1. intra and post-operative blood loss&#xD;
&#xD;
             2. FFP, Transfusion&#xD;
&#xD;
             3. Reoperation for bleeding purpose&#xD;
&#xD;
        4. Others&#xD;
&#xD;
             1. Surgeons satisfaction&#xD;
&#xD;
             2. Easiness of product handling during application (VAS)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">May 2014</completion_date>
  <primary_completion_date type="Anticipated">November 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cardio Vascular Outcome</measure>
    <time_frame>18 months</time_frame>
    <description>To report the effectiveness and safety of COSEAL in the control of anastomotic suture line and needle hole suture bleeding during vascular reconstruction by checking the incidence of immediate anastomotic sealing and the presence of persistent intra-operative and postoperative bleeding</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular (sealing and adhesion prevention):</measure>
    <time_frame>18 months</time_frame>
    <description>To Capture total operative time,nature and duration of first operation,nature and duration of redo operation, and time for dissection from sternotomy to end of dissection for prevention of adhesions )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thoracic and Lung (Sealing and Adhesion prevention)</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">750</enrollment>
  <condition>Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient falling under inclusion criteria can take part in to bthe study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients undergoing cardiovascular and thoracic surgery who require use of Coseal as a&#xD;
             treatment strategy.&#xD;
&#xD;
          2. Patient undergoing open, Video Assisted surgery and robotic surgery to be included and&#xD;
             analysed as subgroups&#xD;
&#xD;
          3. Written informed consent obtained from the patient or legal representative for data&#xD;
             collection post surgery in patients who had Coseal used intraoperatively (data privacy&#xD;
             laws).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known hypersensitivity to components of the investigational product&#xD;
&#xD;
          2. Known Immune system disorders, immunodeficiency&#xD;
&#xD;
          3. Concomitant use of any other anti-adhesion product&#xD;
&#xD;
          4. Concurrently participating in another clinical trial and having received another&#xD;
             investigational drug or device within the last 30 days&#xD;
&#xD;
          5. Unplanned re-operation in case of use for anti-adhesion&#xD;
&#xD;
          6. Contraindications for use of Coseal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Ali Z Khan, MS,FRCS,FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medanta, The Medicity</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dr. Ali Z Khan, MS, FRCS,</last_name>
    <phone>9958001672</phone>
    <email>drkhanresearch@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dr. Shaiwal Khandelwal</last_name>
    <phone>9891878090</phone>
    <email>shaiwalk@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medanta, The Medicity</name>
      <address>
        <city>Gurgaon</city>
        <state>Haryana</state>
        <zip>122 001</zip>
        <country>India</country>
      </address>
    </facility>
    <investigator>
      <last_name>Dr. Ali Z Khan, MS,FRCS,</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>October 12, 2012</last_update_submitted>
  <last_update_submitted_qc>October 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medanta, The Medicity, India</investigator_affiliation>
    <investigator_full_name>Dr. Ali Zamir Khan</investigator_full_name>
    <investigator_title>Head of Department, Minimally Invasive &amp; Robotic Thoracic Surgery</investigator_title>
  </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/NCT01706640
org study id: MM/CTVS/2012/001
nct id: NCT01706640
lead sponsor: 
has dmc: Yes
This study is Open- Label, Observational, Prospective, Real-time data capturing of Usage,
      Outcome & Physician satisfaction of Coseal in Cardio- Vascular-Thoracic Operative and Re-
      Operative procedures.

      Objective of this study is to assess current practice pattern and best practice sharing of
      usage of Coseal by collecting data on (1) Sealing suture lines along arterial and venous
      reconstruction(2) Patients undergoing cardiac surgery to prevent or reduce the incidence,
      severity and extent of post surgical adhesion enforcement of suture lines in lung resection
      procedures (3) From this data to document and generate a real life experience on the use of
      Coseal in cardio vascular and thoracic surgery.

      Number of expected patient enrollment is 750 from 20 participating sites.
Objectives:

        -  Assessing current practice pattern and best practice sharing of usage of Coseal as per
           IFU by collecting data on oSealing suture lines along arterial and venous
           reconstructions oPatients undergoing cardiac surgery to prevent or reduce the incidence,
           severity and extent of post surgical adhesion enforcement of suture and staple lines in
           lung resection procedures

        -  From this data to document and generate a real life experience on the use of Coseal in
           cardio vascular and thoracic surgery

        -  To possibly create a guideline for usage of Sealant in routine practice in India

        -  To study delivery methods and clinical impact in minimally invasive surgery like VATS
           and robotic surgery

      End points

      Primary Endpoint

        1. Cardio vascular sealing:

           To report the effectiveness and safety of COSEAL in the control of anastomotic suture
           line and needle hole suture bleeding during vascular reconstruction by checking the
           incidence of immediate anastomotic sealing and the presence of persistent
           intra-operative and postoperative bleeding average time to achieve hemostasis for a
           single bleeding site after 60 s of clamping without manual compression In case of
           sternotomy, Hemostasis time in mns, which is operative time comprised between the
           removal of cardio-pulmonary bypass cannulae and the closure of the sternum.

           Overall postoperative bleeding in mL/m² revision for bleeding Minor complications, major
           complications, mortality

        2. Efficacy of Coseal in prevention or reduction of adhesion in re-do surgeries for
           patients with staged operations for congenital cardiac malformation re-operated on
           during the follow-up period of the registry

           Incidence of adhesions. location and extension of adhesion by measuring the percentage
           of surface affected for each of the following regions: pericardial or retrosternal,
           inferior or diaphragmatic region, right lateral or atrial region, region around the
           great vessels, pulmonary surface.

           Overall evaluation (dissection easy or difficult) Incidence of subjects free of
           adhesions.

           Severity (at each of these sites, the adhesions will be graded as follows:

           absence of adhesion; 1: filmy and avascular; 2: dense and/or vascular; and 3: cohesive)

        3. Air leak: incidence of immediate (at the time of closure) and prolonged post-operative
           air leak, Use in redo surgery for air leak.

      Secondary Endpoints

        1. Cardiovascular (sealing and adhesion prevention):

             1. Total operative time

             2. Nature and duration of first operation

             3. Nature and duration of redo operation, and time for dissection from sternotomy to
                end of dissection for prevention of adhesions )

             4. Length of intensive care stay

             5. Length of hospital stay

             6. Infection rate

             7. Quality of wound healing

             8. Quality of life (SF36)

        2. Thoracic and Lung

             1. Sealing the suture/ staple line on table Use of buttressing

             2. Total operative time

             3. Drain output

             4. Drain duration

             5. Length of hospital stay

             6. Prolonged air leak (more than 5 days) (>5 days is the new standard for prolonged
                aire leak accepted in 2011 by the EU Soc of CVTS, see ref.)

             7. Infection rate

        3. In all cases,

             1. intra and post-operative blood loss

             2. FFP, Transfusion

             3. Reoperation for bleeding purpose

        4. Others

             1. Surgeons satisfaction

             2. Easiness of product handling during application (VAS)
time perspective: Prospective
measure: Cardio Vascular Outcome
time frame: 18 months
description: To report the effectiveness and safety of COSEAL in the control of anastomotic suture line and needle hole suture bleeding during vascular reconstruction by checking the incidence of immediate anastomotic sealing and the presence of persistent intra-operative and postoperative bleeding
measure: Cardiovascular (sealing and adhesion prevention):
time frame: 18 months
description: To Capture total operative time,nature and duration of first operation,nature and duration of redo operation, and time for dissection from sternotomy to end of dissection for prevention of adhesions )
measure: Thoracic and Lung (Sealing and Adhesion prevention)
time frame: 18 months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Dr. Ali Z Khan, MS,FRCS,FRCS
role: Principal Investigator
affiliation: Medanta, The Medicity
last name: Dr. Ali Z Khan, MS, FRCS,
phone: 9958001672
email: drkhanresearch@gmail.com
last name: Dr. Shaiwal Khandelwal
phone: 9891878090
email: shaiwalk@gmail.com
facility: 
investigator: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Medanta, The Medicity, India
investigator full name: Dr. Ali Zamir Khan
investigator title: Head of Department, Minimally Invasive & Robotic Thoracic Surgery