PillSense for Suspected Upper Gastrointestinal Bleeding (BLEED)

December 5, 2024 updated by: Wee Khoon Ng, Tan Tock Seng Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 hospital's limited resources and may improve overall patient's experience. Patients with 'Blood Detected' result will be admitted with early gastroscopy planned within 72 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 hours. A 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 Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore
        • Recruiting
        • Tan Tock Seng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: PillSense System
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. The PillSense Capsule is a minimally invasive, single use medical device designed to detect the presence of bleeding in the upper digestive tract, to aid with patient care. The PillSense Receiver collects and displays real-time information gathered by the PillSense Capsule within 10 minutes. The PillSense Receiver interprets the data and displays a result message "Blood detected" or "No blood detected".
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discharge rate of patients with stable UGIB who can be triaged home safely after ED visit
Time Frame: 1.5 years
To compare the percentage of patients who are safely discharged from ED visit with the usage of PillSense, compared to standard treatment.
1.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of clinical rebleeding after a negative PillSense reading
Time Frame: 1.5 years
To measure the number of patients who have clinical re-bleeding in both arms.
1.5 years
Discharge rate of patients who can be triaged home using PillSense , compared to conventional clinical scoring system like Glasgow Blatchford Score (GBS).
Time Frame: 1.5 years
To compare what is the percentage of patients who can be discharged safely using PillSense vs Glasgow Blatchford Score alone. The Glasgow Blatchford Score (GBS) is a risk assessment tool to help triage patients presenting with upper gastrointestinal bleeding, if they can be discharged safely from emergency department for outpatient care. The score may range from 0 to 23 and higher scores are associated with higher risks of complications related to gastrointestinal bleeding. Conventional studies recommend that such patients can be safely discharged if the score is 0.
1.5 years
Number of inpatient beds saved from this arrangement
Time Frame: 1.5 years
To review the beds and potential cost savings from the hospital from the reduction of admissions
1.5 years
Risk of patient morbidity after a negative PillSense reading
Time Frame: 1.5 years
To quantify and specify any patient morbidity after a negative PillSense reading.
1.5 years
Risk of patient mortality after a negative PillSense reading
Time Frame: 1.5 years
To quantify and specify any mortality after a negative PillSense reading.
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tan Tock Seng Hospital

Collaborators

EnteraSense Limited

Investigators

  • Principal Investigator: Dr Ng Wee Khoon, Tan Tock Seng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

July 6, 2024

First Submitted That Met QC Criteria

July 12, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/00060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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