HemoPill Acute ® in Suspected Nonvariceal Upper Gastrointestinal Bleeding

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04472364
Study type	Interventional
Source	Wuerzburg University Hospital
Contact
Status	Completed
Phase	N/A
Start date	October 8, 2020
Completion date	April 8, 2024

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