Back to resultsHemoPill Acute ® in Suspected Nonvariceal Upper Gastrointestinal Bleeding
Primary Purpose
Upper Gastrointestinal Bleeding
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
HemoPill Acute ®
Sponsored by
About this trial
This is an interventional diagnostic trial for Upper Gastrointestinal Bleeding focused on measuring Upper Gastrointestinal Bleeding, Capsule endoscopy, Emergency endoscopy
Eligibility Criteria
Inclusion Criteria:
- Emergency presentation with clinical suspicion of non-variceal upper GI bleeding (e.g. haematin vomiting, melena, etc.)
- hemodynamic stable patient (heart rate <100 / min, Blood pressure sys ≥ 100mmHg)
- Emergency endoscopy indicated (modified Glasgow-Blatchford-Score ≥ 2 points)
- Administration of proton pump inhibitors possible (no allergy known)
- Good communication (without translator) with the study doctor and fulfill all requirements of the study
- Written consent after detailed information about the study
Exclusion Criteria:
- Hemodynamically unstable patients (HF> 100 / min, RR <100mmHg despite fluid administration) with indication for endoscopy within 12 hours
- Indication for endoscopy within 12 hours recommended by endoscopy call service
- Clinical suspicion of variceal bleeding of the upper GI tract (risk factors according to german guidelines: cirrhosis of the liver, splanchnic thrombosis, thrombocytopenia, known increased liver / spleen stiffness, known esophageal varices)
- Clinical suspicion of lower GI bleeding (e.g. hematochezia)
- Vomiting blood (hematemesis observed by the emergency doctor or in the clinic)
- Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Severe acute and chronic organ diseases that need treatment (e.g. kidney replacement treatment) (ASA ≥4)
- Changed anatomy of the upper GI tract (e.g. gastric resection)
- Known or suspected gastrointestinal obstructions, strictures, fistulas or known diverticula
- Dysphagia or other swallowing disorders
- Awareness restrictions that make it impossible to swallow the HemoPill Acute ® capsule on your own
- Patients with pacemakers, defibrillators, or other implantable electromedical devices
- Known allergy to parylene (capsule surface)
- Soon MRI scan planned
- Pregnancy or breastfeeding
- Mental impairment that limits the ability to meet all study requirements.
Sites / Locations
- Klinikum FriedrichshainRecruiting
- Universitästklinik FreiburgRecruiting
- Sana Klinikum Offenbach GmbH
- Universitätsklinik WürzburgRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HemoPill
Arm Description
All participants will receive the blood detection capsule HemoPill Acute ®.
Outcomes
Primary Outcome Measures
Rate of avoided emergency endoscopies (usually done within 24 hours) in case of negative HemoPill.
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).
Secondary Outcome Measures
Rate of true positive HemoPill results leading to an emergency endoscopic intervention
HemoPill positive and emergency endoscopy with active bleeding / bleeding source
Rate of false positive HemoPill results
HemoPill positive and emergency endoscopy without active bleeding / bleeding source
Rate of false negative HemoPill results
HemoPill negative and clinical signs of bleeding and confirmation in unscheduled emergency endoscopy
The use of the HemoPill Acute ® capsule as part of emergency care is safe and technically easy.
Measurement of procedural complications
Full Information
NCT ID
NCT04472364
First Posted
July 10, 2020
Last Updated
August 17, 2022
Sponsor
Wuerzburg University Hospital
Collaborators
Vivantes Netzwerk für Gesundheit GmbH, University Hospital Freiburg, Sana Klinikum Offenbach
1. Study Identification
Unique Protocol Identification Number
NCT04472364
Brief Title
HemoPill Acute ® in Suspected Nonvariceal Upper Gastrointestinal Bleeding
Official Title
Impact of Blood Detection Capsule "HemoPill Acute ®" on the Time to Emergency Endoscopy in Case of Suspected Nonvariceal Upper Gastrointestinal Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuerzburg University Hospital
Collaborators
Vivantes Netzwerk für Gesundheit GmbH, University Hospital Freiburg, Sana Klinikum Offenbach
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Gastrointestinal Bleeding
Keywords
Upper Gastrointestinal Bleeding, Capsule endoscopy, Emergency endoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HemoPill
Arm Type
Experimental
Arm Description
All participants will receive the blood detection capsule HemoPill Acute ®.
Intervention Type
Device
Intervention Name(s)
HemoPill Acute ®
Intervention Description
Capsule positive: Endoscopy endoscopy will be performed within 12 hours. Capsule negative: Endoscopy will be performed after 48 to 96 hours.
Primary Outcome Measure Information:
Title
Rate of avoided emergency endoscopies (usually done within 24 hours) in case of negative HemoPill.
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).
Time Frame
48 to 96 hours after swallow the capsule
Secondary Outcome Measure Information:
Title
Rate of true positive HemoPill results leading to an emergency endoscopic intervention
Description
HemoPill positive and emergency endoscopy with active bleeding / bleeding source
Time Frame
12 hours after swallow the capsule
Title
Rate of false positive HemoPill results
Description
HemoPill positive and emergency endoscopy without active bleeding / bleeding source
Time Frame
12 hours after swallow the capsule
Title
Rate of false negative HemoPill results
Description
HemoPill negative and clinical signs of bleeding and confirmation in unscheduled emergency endoscopy
Time Frame
48 to 96 hours after swallow the capsule
Title
The use of the HemoPill Acute ® capsule as part of emergency care is safe and technically easy.
Description
Measurement of procedural complications
Time Frame
30 Days after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Emergency presentation with clinical suspicion of non-variceal upper GI bleeding (e.g. haematin vomiting, melena, etc.)
hemodynamic stable patient (heart rate <100 / min, Blood pressure sys ≥ 100mmHg)
Emergency endoscopy indicated (modified Glasgow-Blatchford-Score ≥ 2 points)
Administration of proton pump inhibitors possible (no allergy known)
Good communication (without translator) with the study doctor and fulfill all requirements of the study
Written consent after detailed information about the study
Exclusion Criteria:
Hemodynamically unstable patients (HF> 100 / min, RR <100mmHg despite fluid administration) with indication for endoscopy within 12 hours
Indication for endoscopy within 12 hours recommended by endoscopy call service
Clinical suspicion of variceal bleeding of the upper GI tract (risk factors according to german guidelines: cirrhosis of the liver, splanchnic thrombosis, thrombocytopenia, known increased liver / spleen stiffness, known esophageal varices)
Clinical suspicion of lower GI bleeding (e.g. hematochezia)
Vomiting blood (hematemesis observed by the emergency doctor or in the clinic)
Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis)
Severe acute and chronic organ diseases that need treatment (e.g. kidney replacement treatment) (ASA ≥4)
Changed anatomy of the upper GI tract (e.g. gastric resection)
Known or suspected gastrointestinal obstructions, strictures, fistulas or known diverticula
Dysphagia or other swallowing disorders
Awareness restrictions that make it impossible to swallow the HemoPill Acute ® capsule on your own
Patients with pacemakers, defibrillators, or other implantable electromedical devices
Known allergy to parylene (capsule surface)
Soon MRI scan planned
Pregnancy or breastfeeding
Mental impairment that limits the ability to meet all study requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Markus Brand, Dr. med.
Phone
+4993120140201
Email
brand_m@ukw.de
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Meining, Prof. Dr.
Phone
+4993120140201
Email
meining_a@ukw.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Meining, Prof. Dr.
Organizational Affiliation
Universital Hospital Würzburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Friedrichshain
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Brunk, Dr. med.
Facility Name
Universitästklinik Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armin Küllmer, Dr. med.
First Name & Middle Initial & Last Name & Degree
Arthur Schmidt, Prof. Dr.
Facility Name
Sana Klinikum Offenbach GmbH
City
Offenbach am Main
ZIP/Postal Code
63069
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edris Wedi, PD Dr. med
First Name & Middle Initial & Last Name & Degree
Annette Hegelein, Dr. med.
Facility Name
Universitätsklinik Würzburg
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Brand, Dr. med.
Phone
+4993120140201
Email
brand_m@ukw.de
First Name & Middle Initial & Last Name & Degree
Alexander Meining, Prof. Dr.
Phone
+4993120140201
Email
meining_a@ukw.de
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HemoPill Acute ® in Suspected Nonvariceal Upper Gastrointestinal Bleeding
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