PillSense for Suspected Upper Gastrointestinal Bleeding
ConditionBleeding Ugi
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-99
SponsorTan Tock Seng Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- PillSense System
Treatment groups
84 Participants
are divided into 2 treatment groupsSponsors and collaborators
Tan Tock Seng Hospital
Lead sponsor
EnteraSense Limited
Collaborator
Source ClinicalTrials.gov