HemoPill Acute ® in Suspected Nonvariceal Upper Gastrointestinal Bleeding

W

Wuerzburg University Hospital

Status

Completed

Conditions

Upper Gastrointestinal Bleeding

Treatments

Device: HemoPill Acute ®

Study type

Interventional

Funder types

Other

Identifiers

NCT04472364
U1111-1254-9251 (Other Identifier)
Brand_HemoPill_07_07_2020

Details and patient eligibility

About

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.

Full 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.

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

73 participants in 1 patient group

HemoPill
Experimental group
Description:
All participants will receive the blood detection capsule HemoPill Acute ®.
Treatment:
Device: HemoPill Acute ®

Trial contacts and locations

4

Loading...

Central trial contact

Alexander Meining, Prof. Dr.; Markus Brand, Dr. med.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems