Actively Recruiting
PillSense for Suspected Upper Gastrointestinal Bleeding
Led by Tan Tock Seng Hospital · Updated on 2024-12-10
84
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
Sponsors
T
Tan Tock Seng Hospital
Lead Sponsor
E
EnteraSense Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PillSense for Suspected Upper Gastrointestinal Bleeding
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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).
You will not qualify if you...
- 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 or 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 dysphagia, odynophagia, swallowing disorder, Zenker's diverticulum, gastrointestinal motility issues, Crohn's disease, previous GI surgery, suspected ileus, bowel obstruction or perforation.
- Patients with a known history of oesophageal or gastric varices.
- Patients with known upper gastrointestinal pathology such as oesophageal or gastric cancer, recent (within 3 months) upper GI ulcer bleeding, or upper GI surgeries or procedures.
- Patients who are on anticoagulation.
- Patients with cardiac implantable electrical devices.
- Patients who had altered mental status.
- Pregnant and/or lactating women (female patients below age 60, without hysterectomy or not documented post-menopausal, will be tested to confirm pregnancy status).
- Patients who have an MRI investigation planned within 2 weeks.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tan Tock Seng Hospital
Singapore, Singapore
Actively Recruiting
Research Team
D
Dr Ng Wee Khoon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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