<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/NCT04406116</url>
  </required_header>
  <id_info>
    <org_study_id>8-HS1-031PRO</org_study_id>
    <nct_id>NCT04406116</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the Safety and Performance of Microwave Coagulation Using the HS1 Instrument</brief_title>
  <official_title>Clinical Evaluation of the Safety and Performance of Microwave Coagulation Using the HS1 Instrument for Actual or Potential Non-variceal Bleeding in the Upper Gastrointestinal (GI) Tract</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Creo Medical Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Creo Medical Limited</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical evaluation of the safety and performance of microwave coagulation using the HS1&#xD;
      Instrument for actual or potential non-variceal bleeding in the upper Gastrointestinal (GI)&#xD;
      tract&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">April 2021</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>Effective coagulation of of actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract.</measure>
    <time_frame>Perioperative</time_frame>
    <description>Primary haemostasis at day 0 using microwave coagulation of active bleeding or pre-coagulation of exposed vessels.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identification and incidence of intra-procedural complications</measure>
    <time_frame>Day 0</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identification and incidence of post-procedural complications</measure>
    <time_frame>At 24-72 hours, 1 week and 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Glasgow-Blatchford score</measure>
    <time_frame>Day 0 for initial screen and then 24-72 hours post-procedure for second score.</time_frame>
    <description>The Glasgow-Blatchford score will be recorded prior to and after microwave intervention</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Questionnaire assessment of device injection features</measure>
    <time_frame>Perioperative</time_frame>
    <description>Endoscopist assessment of injection functionality (questionnaire)</description>
  </other_outcome>
  <other_outcome>
    <measure>Questionnaire assessment of device adhesion characteristics</measure>
    <time_frame>Perioperative</time_frame>
    <description>Endoscopist assessment of tissue sticking (questionnaire)</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Actual or Potential Nonvariceal Bleeding in the Upper Gastrointestinal (GI) Tract</condition>
  <arm_group>
    <arm_group_label>patients receiving microwave therapy using the HS1 Instrument</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Microwave coagulation using HS1 Instrument</intervention_name>
    <description>Microwave therapy at 5.8 GHz</description>
    <arm_group_label>patients receiving microwave therapy using the HS1 Instrument</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient or authorised representative able to comprehend and sign the Informed Consent&#xD;
             form.&#xD;
&#xD;
          -  Actual or potential non-variceal bleeding in the upper GI, including angiodysplasia or&#xD;
             AVM malformations such as Dieulafoy's lesion with a Glasgow-Blatchford score of&#xD;
             greater than 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  As stated in the contraindications in the HS1 IFU;&#xD;
&#xD;
          -  Aged &lt;18 years of age&#xD;
&#xD;
          -  Those described as vulnerable populations in EN ISO 14155;&#xD;
&#xD;
          -  Patients with a known coagulopathy (congenital);&#xD;
&#xD;
          -  Concurrent participation in another experimental intervention or drug study&#xD;
&#xD;
          -  Unwilling or unable to provide informed consent.&#xD;
&#xD;
          -  A patient whose Glasgow-Blatchford score is 1 or less&#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_contact>
    <last_name>dan crocker</last_name>
    <phone>+44 1291 606005</phone>
    <email>dan.crocker@creomedical.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>East Kent Hospitals University Nhs Foundation Trust</name>
      <address>
        <city>Canterbury</city>
        <state>Kent</state>
        <country>United Kingdom</country>
      </address>
    </facility>
    <investigator>
      <last_name>Zacharias P Tsiamoulos, MBBS, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
  </condition_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/NCT04406116
org study id: 8-HS1-031PRO
nct id: NCT04406116
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Clinical evaluation of the safety and performance of microwave coagulation using the HS1
      Instrument for actual or potential non-variceal bleeding in the upper Gastrointestinal (GI)
      tract
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effective coagulation of of actual or potential non-variceal bleeding in the upper Gastrointestinal (GI) tract.
time frame: Perioperative
description: Primary haemostasis at day 0 using microwave coagulation of active bleeding or pre-coagulation of exposed vessels.
measure: Identification and incidence of intra-procedural complications
time frame: Day 0
measure: Identification and incidence of post-procedural complications
time frame: At 24-72 hours, 1 week and 4 weeks
measure: Change in Glasgow-Blatchford score
time frame: Day 0 for initial screen and then 24-72 hours post-procedure for second score.
description: The Glasgow-Blatchford score will be recorded prior to and after microwave intervention
measure: Questionnaire assessment of device injection features
time frame: Perioperative
description: Endoscopist assessment of injection functionality (questionnaire)
measure: Questionnaire assessment of device adhesion characteristics
time frame: Perioperative
description: Endoscopist assessment of tissue sticking (questionnaire)
arm group label: patients receiving microwave therapy using the HS1 Instrument
arm group type: Experimental
intervention type: Device
intervention name: Microwave coagulation using HS1 Instrument
description: Microwave therapy at 5.8 GHz
arm group label: patients receiving microwave therapy using the HS1 Instrument
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: dan crocker
phone: +44 1291 606005
email: dan.crocker@creomedical.com
facility: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Hemorrhage
sharing ipd: No