Usage of Novel Blood Sensing Capsule in Emergency Department to Triage Patients With Suspected Upper Gastrointestinal Bleeding

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 99
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Singapore
Tan Tock Seng Hospital
RECRUITING
Singapore
Contact Information
Primary
Dr Ng Wee Khoon
wee_khoon_ng@ttsh.com.sg
+65 8938 1462
Time Frame
Start Date: 2024-07-18
Estimated Completion Date: 2026-01
Participants
Target number of participants: 84
Treatments
Experimental: PillSense group
Participants in the PillSense arm will swallow one PillSense capsule. Participants who have blood detected will be admitted with a scheduled oesophagogastroduodenoscopy within 72 hours. Participants with no blood detected will be discharged with medications and a scheduled OGD within 96 hours.
No_intervention: Standard group
Participants randomized to the standard arm will follow standard of care and will either be admitted or discharged with medications and to undergo an oesophagogastroduodenoscopy (OGD) within 72 hours if admitted or 96 hours if discharged.
Related Therapeutic Areas
Sponsors
Collaborators: EnteraSense Limited
Leads: Tan Tock Seng Hospital

This content was sourced from clinicaltrials.gov