Status:
RECRUITING
PillSense for Suspected Upper Gastrointestinal Bleeding
Lead Sponsor:
Tan Tock Seng Hospital
Collaborating Sponsors:
EnteraSense Limited
Conditions:
Bleeding Ugi
Eligibility:
All Genders
21-99 years
Phase:
NA
Brief Summary
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 d...
Detailed Description
The use of the PillSense System enables the clinician to make a more informed choice on the treatment plan for the patient. If the system revealed "No Blood Detected", this is suggestive there is abse...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06500468
Start Date
July 18 2024
End Date
January 1 2026
Last Update
December 10 2024
Active Locations (1)
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1
Tan Tock Seng Hospital
Singapore, Singapore