<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/NCT02233933</url>
  </required_header>
  <id_info>
    <org_study_id>RadP</org_study_id>
    <nct_id>NCT02233933</nct_id>
  </id_info>
  <brief_title>Trial of Argon Plasma Coagulation Versus APC and APC and Hemospray in the Treatment of Radiation Proctitis</brief_title>
  <official_title>Randomized Trial of Argon Plasma Coagulation Versus Argon Plasma Coagulation and Hemospray in the Therapy of Radiation Proctitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>British Columbia Cancer Agency</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>British Columbia Cancer Agency</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized trial of Argon Plasma Coagulation compared with Argon Plasma Coagulation and&#xD;
      Hemospray in the therapy of bleeding from Radiation Proctitis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      20 patients with Radiation Proctitis will be randomized to receive either Argon Plasma&#xD;
      Coagulation therapy alone or therapy with APC followed by Hemospray administration ;the&#xD;
      treatment in each arm is administered during a sigmoidoscopic examination&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>cessation of rectal bleeding</measure>
    <time_frame>12 months</time_frame>
    <description>treatment of one group of patients with Radiation Proctitis with Argon Plasma Coagulator ( APC) and a second group will be treated with APC and Hemospray</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of treatments required to achieve cessation of rectal bleeding</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Rectal Bleeding</condition>
  <arm_group>
    <arm_group_label>argon plasma coagulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>argon plasma coagulation of radiation proctitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>argon plasma coagulator and hemospray</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>treatment of radiation proctitis with argon plasma coagulator followed by application of hemospray</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hemospray</intervention_name>
    <description>hemospray is used after argon coagulation to stop bleeding</description>
    <arm_group_label>argon plasma coagulation</arm_group_label>
    <arm_group_label>argon plasma coagulator and hemospray</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  bleeding from radiation proctitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy bleeding diathesis&#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>Alan A Weiss, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BCCA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alan A Weiss, MD</last_name>
    <phone>7789979332</phone>
    <email>aweiss@bccancer.bc.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>British Columbia Cancer Clinic</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Alan A Weiss, MD</last_name>
      <phone>778 9979332</phone>
      <email>aweiss@bccancer.bc.ca</email>
    </contact>
    <investigator>
      <last_name>Alan A Weiss, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>September 8, 2014</last_update_submitted>
  <last_update_submitted_qc>September 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>British Columbia Cancer Agency</investigator_affiliation>
    <investigator_full_name>Alan Weiss</investigator_full_name>
    <investigator_title>Principal Investgator</investigator_title>
  </responsible_party>
  <keyword>radiation proctitis</keyword>
  <keyword>bleeding</keyword>
  <keyword>therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Proctitis</mesh_term>
    <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/NCT02233933
org study id: RadP
nct id: NCT02233933
lead sponsor: 
has dmc: Yes
Randomized trial of Argon Plasma Coagulation compared with Argon Plasma Coagulation and
      Hemospray in the therapy of bleeding from Radiation Proctitis
20 patients with Radiation Proctitis will be randomized to receive either Argon Plasma
      Coagulation therapy alone or therapy with APC followed by Hemospray administration ;the
      treatment in each arm is administered during a sigmoidoscopic examination
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: cessation of rectal bleeding
time frame: 12 months
description: treatment of one group of patients with Radiation Proctitis with Argon Plasma Coagulator ( APC) and a second group will be treated with APC and Hemospray
measure: number of treatments required to achieve cessation of rectal bleeding
time frame: 12 months
arm group label: argon plasma coagulation
arm group type: Active Comparator
description: argon plasma coagulation of radiation proctitis
arm group label: argon plasma coagulator and hemospray
arm group type: Experimental
description: treatment of radiation proctitis with argon plasma coagulator followed by application of hemospray
intervention type: Other
intervention name: Hemospray
description: hemospray is used after argon coagulation to stop bleeding
arm group label: argon plasma coagulation
arm group label: argon plasma coagulator and hemospray
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alan A Weiss, MD
role: Principal Investigator
affiliation: BCCA
last name: Alan A Weiss, MD
phone: 7789979332
email: aweiss@bccancer.bc.ca
facility: 
contact: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: British Columbia Cancer Agency
investigator full name: Alan Weiss
investigator title: Principal Investgator
mesh term: Proctitis
mesh term: Hemorrhage