<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/NCT04472364</url>
  </required_header>
  <id_info>
    <org_study_id>Brand_HemoPill_07_07_2020</org_study_id>
    <secondary_id>U1111-1254-9251</secondary_id>
    <nct_id>NCT04472364</nct_id>
  </id_info>
  <brief_title>HemoPill Acute ® in Suspected Nonvariceal Upper Gastrointestinal Bleeding</brief_title>
  <official_title>Impact of Blood Detection Capsule &quot;HemoPill Acute ®&quot; on the Time to Emergency Endoscopy in Case of Suspected Nonvariceal Upper Gastrointestinal Bleeding</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuerzburg University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vivantes Netzwerk für Gesundheit GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Freiburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sana Klinikum Offenbach</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wuerzburg University Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study examines, whether the use of the HemoPill Acute ® capsule in case of suspected&#xD;
      nonvariceal upper gastrointestinal bleeding can identify cases in which endoscopy can be&#xD;
      delayed to 48-96 hours without risk to the patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite a variety of scoring systems (Glasgow-Blatchford-Score, etc.) timing of endoscopy in&#xD;
      case of suspecting nonvariceal bleeding in the upper gastrointestinal tract is still&#xD;
      challenging.&#xD;
&#xD;
      While very early endoscopy (within 12 hours) is required in some cases, European Society of&#xD;
      Gastrointestinal Endoscopy (ESGE) - guidelines recommend performing emergency endoscopy&#xD;
      within 24 hours in other cases. However, a recent study (Siau et al. 2019) showed that even&#xD;
      this time window is only kept in 59% of cases. Therefore this study examines, whether the use&#xD;
      of the HemoPill Acute ® capsule in case of suspected nonvariceal upper gastrointestinal&#xD;
      bleeding, can identify cases in which endoscopy can be delayed to 48-96 hours without risk to&#xD;
      the patient.&#xD;
&#xD;
      In this study, after the routine administration of a proton pump inhibitor, hemodynamically&#xD;
      stable emergency patients suspected of having non-variceal bleeding in the upper&#xD;
      gastrointestinal tract receive a novel blood detection capsule (HemoPill Acute ®) for&#xD;
      swallowing, whose result is available after 2 hours.&#xD;
&#xD;
      In case of blood detection in the upper gi-tract (capsule positive), the endoscopy will be&#xD;
      performed within 12 hours.&#xD;
&#xD;
      If no blood is found in the upper GI tract (capsule negative), endoscopy will be performed&#xD;
      after 48 to 96 hours, with the patient being monitored in hospital until then. In these&#xD;
      cases, if clinical bleeding occurs before the planned endoscopy, the patient will receive an&#xD;
      unscheduled emergency endoscopy.&#xD;
&#xD;
      Further treatment is carried out according to current clinical standards. 30 days after&#xD;
      discharge, the patients will be asked by telephone about their further clinical course and&#xD;
      possible complications.&#xD;
&#xD;
      This study is supported by Ovesco Endoscopy AG by making the capsule available free of&#xD;
      Charge. The study is planned to recruit 72 participants over 48 months in several centers. If&#xD;
      this procedure is found to be safe, the HemoPill Acute ® capsule can be used to reduce the&#xD;
      number of emergency endoscopies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 8, 2020</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">October 2024</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>
    <intervention_model_description>All participants will receive the HemoPill Acute ® capsule. In case of blood detection in the upper gi-tract (capsule positive), the endoscopy will be performed within 12 hours. If no blood is found in the upper GI tract (capsule negative), endoscopy will be performed after 48 to 96 hours.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of avoided emergency endoscopies (usually done within 24 hours) in case of negative HemoPill.</measure>
    <time_frame>48 to 96 hours after swallow the capsule</time_frame>
    <description>In how many cases with a negative HaemoPill, the endoscopy interval can be extended to at least 48 hours without acute re-bleeding (confirmed in unscheduled emergency endoscopy) occurring in the meantime.&#xD;
The criteria for suspected re-bleeding (leading to an unscheduled emergency endoscopy) are: Hematemesis, again melena or hematochezia after normalized stool, tachycardia (≥110 / min) or hypotension (RRsys ≤90 mm Hg) without other explanation, decrease in the Hb value ≥2 g/dl in the course without other explanation (e.g. dilution, nosebleeds ), no increase in Hb after transfusion of erythrocyte concentrate (s) (measured after 24 hours).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of true positive HemoPill results leading to an emergency endoscopic intervention</measure>
    <time_frame>12 hours after swallow the capsule</time_frame>
    <description>HemoPill positive and emergency endoscopy with active bleeding / bleeding source</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of false positive HemoPill results</measure>
    <time_frame>12 hours after swallow the capsule</time_frame>
    <description>HemoPill positive and emergency endoscopy without active bleeding / bleeding source</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of false negative HemoPill results</measure>
    <time_frame>48 to 96 hours after swallow the capsule</time_frame>
    <description>HemoPill negative and clinical signs of bleeding and confirmation in unscheduled emergency endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The use of the HemoPill Acute ® capsule as part of emergency care is safe and technically easy.</measure>
    <time_frame>30 Days after discharge</time_frame>
    <description>Measurement of procedural complications</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Upper Gastrointestinal Bleeding</condition>
  <arm_group>
    <arm_group_label>HemoPill</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will receive the blood detection capsule HemoPill Acute ®.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HemoPill Acute ®</intervention_name>
    <description>Capsule positive: Endoscopy endoscopy will be performed within 12 hours. Capsule negative: Endoscopy will be performed after 48 to 96 hours.</description>
    <arm_group_label>HemoPill</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Emergency presentation with clinical suspicion of non-variceal upper GI bleeding (e.g.&#xD;
             haematin vomiting, melena, etc.)&#xD;
&#xD;
          -  hemodynamic stable patient (heart rate &lt;100 / min, Blood pressure sys ≥ 100mmHg)&#xD;
&#xD;
          -  Emergency endoscopy indicated (modified Glasgow-Blatchford-Score ≥ 2 points)&#xD;
&#xD;
          -  Administration of proton pump inhibitors possible (no allergy known)&#xD;
&#xD;
          -  Good communication (without translator) with the study doctor and fulfill all&#xD;
             requirements of the study&#xD;
&#xD;
          -  Written consent after detailed information about the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemodynamically unstable patients (HF&gt; 100 / min, RR &lt;100mmHg despite fluid&#xD;
             administration) with indication for endoscopy within 12 hours&#xD;
&#xD;
          -  Indication for endoscopy within 12 hours recommended by endoscopy call service&#xD;
&#xD;
          -  Clinical suspicion of variceal bleeding of the upper GI tract (risk factors according&#xD;
             to german guidelines: cirrhosis of the liver, splanchnic thrombosis, thrombocytopenia,&#xD;
             known increased liver / spleen stiffness, known esophageal varices)&#xD;
&#xD;
          -  Clinical suspicion of lower GI bleeding (e.g. hematochezia)&#xD;
&#xD;
          -  Vomiting blood (hematemesis observed by the emergency doctor or in the clinic)&#xD;
&#xD;
          -  Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis)&#xD;
&#xD;
          -  Severe acute and chronic organ diseases that need treatment (e.g. kidney replacement&#xD;
             treatment) (ASA ≥4)&#xD;
&#xD;
          -  Changed anatomy of the upper GI tract (e.g. gastric resection)&#xD;
&#xD;
          -  Known or suspected gastrointestinal obstructions, strictures, fistulas or known&#xD;
             diverticula&#xD;
&#xD;
          -  Dysphagia or other swallowing disorders&#xD;
&#xD;
          -  Awareness restrictions that make it impossible to swallow the HemoPill Acute ® capsule&#xD;
             on your own&#xD;
&#xD;
          -  Patients with pacemakers, defibrillators, or other implantable electromedical devices&#xD;
&#xD;
          -  Known allergy to parylene (capsule surface)&#xD;
&#xD;
          -  Soon MRI scan planned&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Mental impairment that limits the ability to meet all study requirements.&#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>Alexander Meining, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universital Hospital Würzburg</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Markus Brand, Dr. med.</last_name>
    <phone>+4993120140201</phone>
    <email>brand_m@ukw.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alexander Meining, Prof. Dr.</last_name>
    <phone>+4993120140201</phone>
    <email>meining_a@ukw.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Klinikum Friedrichshain</name>
      <address>
        <city>Berlin</city>
        <zip>10249</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Brunk, Dr. med.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitästklinik Freiburg</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Armin Küllmer, Dr. med.</last_name>
    </contact>
    <contact_backup>
      <last_name>Arthur Schmidt, Prof. Dr.</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Sana Klinikum Offenbach GmbH</name>
      <address>
        <city>Offenbach am Main</city>
        <zip>63069</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Edris Wedi, PD Dr. med</last_name>
    </contact>
    <contact_backup>
      <last_name>Annette Hegelein, Dr. med.</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik Würzburg</name>
      <address>
        <city>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Markus Brand, Dr. med.</last_name>
      <phone>+4993120140201</phone>
      <email>brand_m@ukw.de</email>
    </contact>
    <contact_backup>
      <last_name>Alexander Meining, Prof. Dr.</last_name>
      <phone>+4993120140201</phone>
      <email>meining_a@ukw.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>August 17, 2022</last_update_submitted>
  <last_update_submitted_qc>August 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wuerzburg University Hospital</investigator_affiliation>
    <investigator_full_name>Dr. med. Markus Brand</investigator_full_name>
    <investigator_title>Senior Physician - Gastroenterologist</investigator_title>
  </responsible_party>
  <keyword>Upper Gastrointestinal Bleeding</keyword>
  <keyword>Capsule endoscopy</keyword>
  <keyword>Emergency endoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Hemorrhage</mesh_term>
    <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/NCT04472364
org study id: Brand_HemoPill_07_07_2020
secondary id: U1111-1254-9251
nct id: NCT04472364
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study examines, whether the use of the HemoPill Acute ® capsule in case of suspected
      nonvariceal upper gastrointestinal bleeding can identify cases in which endoscopy can be
      delayed to 48-96 hours without risk to the patient.
Despite a variety of scoring systems (Glasgow-Blatchford-Score, etc.) timing of endoscopy in
      case of suspecting nonvariceal bleeding in the upper gastrointestinal tract is still
      challenging.

      While very early endoscopy (within 12 hours) is required in some cases, European Society of
      Gastrointestinal Endoscopy (ESGE) - guidelines recommend performing emergency endoscopy
      within 24 hours in other cases. However, a recent study (Siau et al. 2019) showed that even
      this time window is only kept in 59% of cases. Therefore this study examines, whether the use
      of the HemoPill Acute ® capsule in case of suspected nonvariceal upper gastrointestinal
      bleeding, can identify cases in which endoscopy can be delayed to 48-96 hours without risk to
      the patient.

      In this study, after the routine administration of a proton pump inhibitor, hemodynamically
      stable emergency patients suspected of having non-variceal bleeding in the upper
      gastrointestinal tract receive a novel blood detection capsule (HemoPill Acute ®) for
      swallowing, whose result is available after 2 hours.

      In case of blood detection in the upper gi-tract (capsule positive), the endoscopy will be
      performed within 12 hours.

      If no blood is found in the upper GI tract (capsule negative), endoscopy will be performed
      after 48 to 96 hours, with the patient being monitored in hospital until then. In these
      cases, if clinical bleeding occurs before the planned endoscopy, the patient will receive an
      unscheduled emergency endoscopy.

      Further treatment is carried out according to current clinical standards. 30 days after
      discharge, the patients will be asked by telephone about their further clinical course and
      possible complications.

      This study is supported by Ovesco Endoscopy AG by making the capsule available free of
      Charge. The study is planned to recruit 72 participants over 48 months in several centers. If
      this procedure is found to be safe, the HemoPill Acute ® capsule can be used to reduce the
      number of emergency endoscopies.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All participants will receive the HemoPill Acute ® capsule. In case of blood detection in the upper gi-tract (capsule positive), the endoscopy will be performed within 12 hours. If no blood is found in the upper GI tract (capsule negative), endoscopy will be performed after 48 to 96 hours.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Rate of avoided emergency endoscopies (usually done within 24 hours) in case of negative HemoPill.
time frame: 48 to 96 hours after swallow the capsule
description: In how many cases with a negative HaemoPill, the endoscopy interval can be extended to at least 48 hours without acute re-bleeding (confirmed in unscheduled emergency endoscopy) occurring in the meantime.
The criteria for suspected re-bleeding (leading to an unscheduled emergency endoscopy) are: Hematemesis, again melena or hematochezia after normalized stool, tachycardia (≥110 / min) or hypotension (RRsys ≤90 mm Hg) without other explanation, decrease in the Hb value ≥2 g/dl in the course without other explanation (e.g. dilution, nosebleeds ), no increase in Hb after transfusion of erythrocyte concentrate (s) (measured after 24 hours).
measure: Rate of true positive HemoPill results leading to an emergency endoscopic intervention
time frame: 12 hours after swallow the capsule
description: HemoPill positive and emergency endoscopy with active bleeding / bleeding source
measure: Rate of false positive HemoPill results
time frame: 12 hours after swallow the capsule
description: HemoPill positive and emergency endoscopy without active bleeding / bleeding source
measure: Rate of false negative HemoPill results
time frame: 48 to 96 hours after swallow the capsule
description: HemoPill negative and clinical signs of bleeding and confirmation in unscheduled emergency endoscopy
measure: The use of the HemoPill Acute ® capsule as part of emergency care is safe and technically easy.
time frame: 30 Days after discharge
description: Measurement of procedural complications
arm group label: HemoPill
arm group type: Experimental
description: All participants will receive the blood detection capsule HemoPill Acute ®.
intervention type: Device
intervention name: HemoPill Acute ®
description: Capsule positive: Endoscopy endoscopy will be performed within 12 hours. Capsule negative: Endoscopy will be performed after 48 to 96 hours.
arm group label: HemoPill
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexander Meining, Prof. Dr.
role: Principal Investigator
affiliation: Universital Hospital Würzburg
last name: Markus Brand, Dr. med.
phone: +4993120140201
email: brand_m@ukw.de
last name: Alexander Meining, Prof. Dr.
phone: +4993120140201
email: meining_a@ukw.de
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Wuerzburg University Hospital
investigator full name: Dr. med. Markus Brand
investigator title: Senior Physician - Gastroenterologist
mesh term: Gastrointestinal Hemorrhage
mesh term: Hemorrhage
sharing ipd: No