HemoPill Acute ® in Suspected Nonvariceal Upper Gastrointestinal Bleeding

Impact of Blood Detection Capsule "HemoPill Acute ®" on the Time to Emergency Endoscopy in Case of Suspected Nonvariceal Upper Gastrointestinal Bleeding

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.

Study Overview

• Status: Completed
• Conditions: Upper Gastrointestinal Bleeding
• Intervention / Treatment: Device: HemoPill Acute ®

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.

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.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10249
    • Klinikum Friedrichshain
  • Freiburg, Germany, 79106
    • Universitästklinik Freiburg
  • Offenbach am Main, Germany, 63069
    • Sana Klinikum Offenbach GmbH
  • Würzburg, Germany, 97080
    • Universitätsklinik Würzburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HemoPill; All participants will receive the blood detection capsule HemoPill Acute ®.	Device: HemoPill Acute ®; Capsule positive: Endoscopy endoscopy will be performed within 12 hours. Capsule negative: Endoscopy will be performed after 48 to 96 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	48 to 96 hours after swallow the capsule

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of true positive HemoPill results leading to an emergency endoscopic intervention	HemoPill positive and emergency endoscopy with active bleeding / bleeding source	12 hours after swallow the capsule
Rate of false positive HemoPill results	HemoPill positive and emergency endoscopy without active bleeding / bleeding source	12 hours after swallow the capsule
Rate of false negative HemoPill results	HemoPill negative and clinical signs of bleeding and confirmation in unscheduled emergency endoscopy	48 to 96 hours after swallow the capsule
The use of the HemoPill Acute ® capsule as part of emergency care is safe and technically easy.	Measurement of procedural complications	30 Days after discharge

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital
• Collaborators: University Hospital Freiburg; Sana Klinikum Offenbach; Vivantes Netzwerk für Gesundheit GmbH
• Investigators: Principal Investigator: Alexander Meining, Prof. Dr., Universital Hospital Würzburg

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Actual): April 8, 2024
• Study Completion (Actual): April 8, 2024

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Capsule endoscopy; Upper Gastrointestinal Bleeding; Emergency endoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: Brand_HemoPill_07_07_2020; U1111-1254-9251 (Other Identifier: WHO Universal Trail Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No