💬In plain words
What the trial is, and whether it could suit you
This study aims to evaluate the efficacy and safety of a novel blood sensing capsule (PillSense), to help emergency doctors better evaluate if patients have active upper digestive tract bleeding, to determine if they can be discharged safely. The PillSense System consists of the PillSense Capsule, a small single use capsule that is safe for human consumption and PillSense Receiver, an external real-time monitor for data display to detect the presence of bleeding in the upper digestive tract within 10 minutes.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Males or females aged 21 years and above and are able to give consent.
* Patients who are willing and able to comply with the study protocol (including undergoing endoscopy)
* Presented to Emergency Department with symptoms of acute overt upper gastrointestinal bleeding such as coffee ground vomiting and melena (but without melaena on physical examination)
Exclusion Criteria:
* Patients who had hemodynamic shock (systolic blood pressure below 90 mm Hg and pulse rate over 120/min)
* Patients who presented with fresh hematemesis, hematochezia and/or melaena
* Patients requiring urgent endoscopy / surgery at time of review or already planned for admission by ED physician for non UGIB related indications
* Patients who had conditions that might contraindicate the use of an ingestible capsule, such as capsule endoscopy (eg. Dysphagia, odynophagia, swallowing disorder, and/or Zenker's diverticulum, issues with the motility of the gastrointestinal tract, Crohn's disease, previous GI surgery, suspected ileus, bowel obstruction and/or perforation)
* Patients with a known history of oesophageal or gastric varices
* Patients with known UGI pathology (such as oesophageal/gastric cancer), or recent (within 3 months) upper GI ulcer bleeding, upper GI surgeries or procedures
* Patients who are on anticoagulation
* Patients with cardiac implantable electrical device (CIED)
* Patients who had altered mental status
* Pregnant and/or lactating women (Female patients below age 60, without history of hysterectomy or are not documented to be post-menopausal, will be given a urine pregnancy test to confirm they are not pregnant)
* Patients who have an MRI investigation planned within 2 weeks
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