Upper gastrointestinal bleeding Digestive System
Conditions
Interventions
The PillSense system refers to an ingestible capsule designed to detect blood in the stomach and transmit real-time data to an external receiver. The PillSense System consists of two main components:
Sponsors
Enterasense Limited
Eligibility
Sex/Gender
All
Age
18 Years to 84 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged = 18 and < 85 years old 2. Presented to Emergency Department with symptoms of acute overt upper gastrointestinal bleeding such as coffee ground vomiting, haematemesis, or melaena* 3. Glasgow-Blatchford score of 2-5 on presentation 4. Patients who are willing and able to comply with the study protocol (including undergoing endoscopy). 5. Willing and able to give written informed consent** *The presence of witnessed haematemesis within the department on arrival/admission will be an exclusion criterion. **The use of a formal translator will be accepted
Exclusion criteria
Exclusion criteria: 1. Haemodynamic instability (systolic blood pressure =100 mmHg or heart rate =100 bpm)* 2. Clear need for urgent endoscopy or surgery as determined by the treating physician 3. Need for red blood cell transfusion 4. Active fresh haematemesis or haematochezia 5. The presence of any condition that would be a contraindication to the use of the ingestible PillSense Capsule: 5.1. Known or suspected gastrointestinal strictures 5.2. Dysphagia or odynophagia 5.3. History of achalasia or oesophageal dysmotility 5.4. History of gastroparesis 5.5. Zenker's diverticulum 5.6. Active Crohn's disease 5.7. Recent gastrointestinal surgery (within 6 months) 5.8. Suspected ileus or bowel obstruction 6. Known liver disease with advanced fibrosis/cirrhosis 7. Known history of oesophageal or gastric varices 8. Known upper gastrointestinal pathology that may predispose to bleeding, which has been diagnosed (e.g. ulcer) or treated (e.g. endoscopic submucosal dissection) within the last three months 9. Suspicion of an obstructing gastrointestinal tumour 10. Currently pregnant or breastfeeding, or intend to become pregnant during the investigation 11. Planned MRI within the next 30-days, which cannot be delayed 12. Presence of an implantable electrical device (e.g. cardiac, deep brain stimulator) 13. Unable to take anti-secretory medication (e.g. PPI or HR2A) 14. Use of medication prior to admission to stimulate gastric motility (e.g. prucalopride, domperidone, metoclopramide) 15. Altered mental status precluding informed consent 16. Use of dual anti-platelet therapy 17. Use of a direct oral anticoagulant with at least one anti-platelet agent 18. Myocardial infarction and/or percutaneous coronary intervention within the last 12 months 19. Any other mental or physical condition which, in the opinion of the investigator, makes the subject a poor candidate for clinical-trial participation 20. Any participant currently enrolled in another study investigating a medical device or investigational medicinal product (IMP). *Confirmed on two assessments at least 15 minutes
Countries
England, United Kingdom
Contacts
Public ContactBenjamin Norton
Outcome results
None listed