NCT04472364

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Wuerzburg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Upper Gastrointestinal Bleeding

Interventions

Type	Name	Description
DEVICE	HemoPill Acute ®	Capsule positive: Endoscopy endoscopy will be performed within 12 hours. Capsule negative: Endoscopy will be performed after 48 to 96 hours.

Timeline

• Start date: 2020-10-08
• Primary completion: 2024-04-08
• Completion: 2024-04-08
• First posted: 2020-07-15
• Last updated: 2024-07-10

Locations

4 sites across 1 country: Germany