<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/NCT02264730</url>
  </required_header>
  <id_info>
    <org_study_id>10-030H2</org_study_id>
    <nct_id>NCT02264730</nct_id>
  </id_info>
  <brief_title>ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery - Liver Bleeding is Encountered</brief_title>
  <official_title>Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery in Which Liver Bleeding is Encountered</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biomedica Management Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Biomedica Management Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery&#xD;
      in Which Liver Bleeding is Encountered.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In any open surgery bleeding usually occurs. Surgeons try to stop the bleeding by using&#xD;
      his/her usual surgical practice. These include, but are not limited to: suturing (stitches),&#xD;
      ligation (tying up) or cautery (to burn in order to stop or prevent bleeding). It is often&#xD;
      necessary for surgeons to use an additional treatment to stop the bleeding. This may include&#xD;
      the use of a hemostatic product (used to stop bleeding).&#xD;
&#xD;
      This Phase I study consists of a single arm evaluating the safety of ClotFoam as an adjunct&#xD;
      to hemostasis. ClotFoam® is an investigational product-a gelatin-based hydrogel carrying a&#xD;
      fibrin monomer-that has been designed for supportive treatment in general surgery for the&#xD;
      improvement of hemostasis, where standard techniques are insufficient.&#xD;
&#xD;
      The evaluation will be conducted in 24 patients who are scheduled to undergo elective open&#xD;
      surgery in which liver bleeding is encountered requiring control of mild-to- moderate&#xD;
      bleeding where standard surgical techniques are expected to be ineffective and/or&#xD;
      impractical. All subjects who meet eligibility criteria and who provide informed consent to&#xD;
      participate will be assigned to ClotFoam topical treatment. Subjects who will be screened for&#xD;
      eligibility to participate in this study will be those who are scheduled to with undergo an&#xD;
      elective (non-emergency) hepatic wedge resection or anatomic resection (of 1 to 5 contiguous&#xD;
      hepatic segments or a surgical procedure in which liver bleeding is encountered such as&#xD;
      removal of the gall bladder (open), bile duct excision wherein an appropriate target bleeding&#xD;
      site is identified.&#xD;
&#xD;
      Subjects undergoing living-related liver donation are also eligible. Participants will have&#xD;
      post-operative follow ups at day 1,2,5, and 10 post-procedure, 2 weeks post procedure, and 12&#xD;
      weeks post-procedure. The follow up visits will consist of safety evaluations (physical exam,&#xD;
      adverse event assessment, laboratory evaluations).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">January 2015</completion_date>
  <primary_completion_date type="Anticipated">January 2015</primary_completion_date>
  <phase>Phase 1</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>control mild-to-moderate bleeding during surgery in which liver bleeding in encountered</measure>
    <time_frame>12 weeks</time_frame>
    <description>evaluated intermittently during those 12 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemostatic Success</measure>
    <time_frame>1 minute</time_frame>
    <description>Percentage of subjects who achieve hemostatic success within the 1-minute TTH assessment period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemostatic Success</measure>
    <time_frame>5 minutes</time_frame>
    <description>Percentage of subjects who achieve hemostatic success within the 5-minute TTH assessment period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemostatic Success</measure>
    <time_frame>10 minutes</time_frame>
    <description>Percentage of subjects who achieve hemostatic success within the 10- minute TTH period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemostatic Success</measure>
    <time_frame>10 minutes</time_frame>
    <description>Incidence of treatment failures (if hemostasis is not achieved within 10 minutes or if bleeding required additional intervention during the 2nd 10 minute observation period.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Bleeding</condition>
  <arm_group>
    <arm_group_label>Clot Foam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Application of Clotfoam</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ClotFoam</intervention_name>
    <description>Patient has not received blood products between screenings</description>
    <arm_group_label>Clot Foam</arm_group_label>
    <other_name>No other names</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is expected to survive 6 months from the date of screening, If female and of&#xD;
             child-bearing potential, subject has a negative serum pregnancy test prior to surgery&#xD;
             and agrees to not breast feed her child (if applicable) for duration of study&#xD;
             treatment and completion of study follow-up visits, If subject is a sexually active&#xD;
             male or a sexually active female of child-bearing potential, subject agrees to use a&#xD;
             medically accepted form of contraception from the time of consent to completion of all&#xD;
             follow-up study visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant females&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Grant Bochicchio, MD, MPH FACS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine Barnes Jewish Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine Barnes Jewish Hospital Clinical Laboratory</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63130</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Grant Bochicchio, MD, MPH FACS</last_name>
      <phone>314-747-3000</phone>
    </contact>
    <contact_backup>
      <last_name>Jessica Smith, MD</last_name>
      <phone>(314) 747-3000</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 14, 2014</last_update_submitted>
  <last_update_submitted_qc>October 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Biomedica Management Corporation</investigator_affiliation>
    <investigator_full_name>George Falus</investigator_full_name>
    <investigator_title>President</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <!-- 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/NCT02264730
org study id: 10-030H2
nct id: NCT02264730
lead sponsor: 
collaborator: 
has dmc: Yes
Phase 1 Single-Arm Study Evaluating ClotFoam as an Adjunct to Hemostasis in Abdominal Surgery
      in Which Liver Bleeding is Encountered.
In any open surgery bleeding usually occurs. Surgeons try to stop the bleeding by using
      his/her usual surgical practice. These include, but are not limited to: suturing (stitches),
      ligation (tying up) or cautery (to burn in order to stop or prevent bleeding). It is often
      necessary for surgeons to use an additional treatment to stop the bleeding. This may include
      the use of a hemostatic product (used to stop bleeding).

      This Phase I study consists of a single arm evaluating the safety of ClotFoam as an adjunct
      to hemostasis. ClotFoam® is an investigational product-a gelatin-based hydrogel carrying a
      fibrin monomer-that has been designed for supportive treatment in general surgery for the
      improvement of hemostasis, where standard techniques are insufficient.

      The evaluation will be conducted in 24 patients who are scheduled to undergo elective open
      surgery in which liver bleeding is encountered requiring control of mild-to- moderate
      bleeding where standard surgical techniques are expected to be ineffective and/or
      impractical. All subjects who meet eligibility criteria and who provide informed consent to
      participate will be assigned to ClotFoam topical treatment. Subjects who will be screened for
      eligibility to participate in this study will be those who are scheduled to with undergo an
      elective (non-emergency) hepatic wedge resection or anatomic resection (of 1 to 5 contiguous
      hepatic segments or a surgical procedure in which liver bleeding is encountered such as
      removal of the gall bladder (open), bile duct excision wherein an appropriate target bleeding
      site is identified.

      Subjects undergoing living-related liver donation are also eligible. Participants will have
      post-operative follow ups at day 1,2,5, and 10 post-procedure, 2 weeks post procedure, and 12
      weeks post-procedure. The follow up visits will consist of safety evaluations (physical exam,
      adverse event assessment, laboratory evaluations).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: control mild-to-moderate bleeding during surgery in which liver bleeding in encountered
time frame: 12 weeks
description: evaluated intermittently during those 12 weeks
measure: Hemostatic Success
time frame: 1 minute
description: Percentage of subjects who achieve hemostatic success within the 1-minute TTH assessment period.
measure: Hemostatic Success
time frame: 5 minutes
description: Percentage of subjects who achieve hemostatic success within the 5-minute TTH assessment period.
measure: Hemostatic Success
time frame: 10 minutes
description: Percentage of subjects who achieve hemostatic success within the 10- minute TTH period.
measure: Hemostatic Success
time frame: 10 minutes
description: Incidence of treatment failures (if hemostasis is not achieved within 10 minutes or if bleeding required additional intervention during the 2nd 10 minute observation period.
arm group label: Clot Foam
arm group type: Experimental
description: Application of Clotfoam
intervention type: Drug
intervention name: ClotFoam
description: Patient has not received blood products between screenings
arm group label: Clot Foam
other name: No other names
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Grant Bochicchio, MD, MPH FACS
role: Principal Investigator
affiliation: Washington University School of Medicine Barnes Jewish Hospital
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Biomedica Management Corporation
investigator full name: George Falus
investigator title: President
mesh term: Hemorrhage