Pillsense system for the RIsk stratification Of suspected upper gastRointestinal bleeding to Improve the Triage of patIentS at modErate-risk: a randomised controlled trial
Upper gastrointestinal bleeding
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: 1. An ingestible capsule: A non-invasive, single-use device designed to detect blood in the stomach (dimensions: 11×27 mm). 2. An external receiver: A device that receives and displays real-time data transmitted from the capsule. The PillSense System is designed to complement standard care by providing clinicians with critical information regarding the presence of blood in the stomach. This information can have significant implications for patient care and outcomes, clinical resource utilisation, and healthcare costs. The PillSense system could aid the diagnosis of upper gastrointestinal bleeding and contribute to more efficient resource allocation and improved patient care through the emergency setting. Patients presenting with a suspected upper gastrointestinal bleed who are deemed at moderate risk based on the Glasgow-Blatchford score will be randomised 1:1 to receive PillSense or standard of care using a central web-based system with concealed allocation. Investigators and participants will be unblinded to the group allocation. If participants have been allocated to receive PillSense, they will proceed with the administration of the capsule. Participants randomised to standard of care or PillSense with a positive (“Blood detected”) result will be advised to undergo an inpatient endoscopy within 24-hours of admission according to standard practice for the management of upper gastrointestinal bleeding. All procedures will be completed according to standard operating procedures at each site. Participants randomised to PillSense with a negative (“Blood not detected”) result will be discharged and undergo an outpatient endoscopy within 5-days of the index presentation according to the standard operating procedure at each site. All participants randomised will undergo a
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
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 m