Ignite Creation Date:
2024-07-17 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500468
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-06
Brief Title:
PillSense for Suspected Upper Gastrointestinal Bleeding
Sponsor:
Tan Tock Seng Hospital
Organization:
Tan Tock Seng Hospital
Study Overview
Official Title:
Usage of Novel Blood Sensing Capsule in Emergency Department to Triage Patients With Suspected Upper Gastrointestinal Bleeding
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BLEED
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 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
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 absence of blood in the stomach Together with the presenting symptoms physical examination and laboratory tests it gives the emergency physician a more accurate method to detect if patient is actively bleeding If patient remained stable during the monitoring the patient can be discharged home for early outpatient review instead of waiting in Emergency Department ED for prolonged duration to be admitted and wait in the ward for investigations like gastroscopy to be performed This reduces unnecessary strain on the hospitals limited resources and may improve overall patients experience Patients with Blood Detected result will be admitted with early gastroscopy planned within 30 hours Patients with No Blood Detected result will be monitored closely in ED and if deemed to be stable to be discharged with an outpatient gastroscopy within 96 hoursA product such as the PillSense System which employs a minimally invasive method to help clinicians detect whether or not a patient has blood in upper gastrointestinal tract within 10 minutes This will be a quick and objective tool to determine if the patient is having active upper gastrointestinal bleeding UGIB to assist in triaging patients for more emergent definitive care This system can also be easily administered by non-clinician and do not require special training to read the results minimising the need for highly specialised staff to provide this service The information provided by the PillSense System which taken together with other clinical parameters may lead to more efficient safer and higher quality patient care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None