Health TrialsbyHealthPanel

PillSense for Suspected Upper Gastrointestinal Bleeding

ConditionBleeding Ugi
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-99
SponsorTan Tock Seng Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • PillSense System

    Device

    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".

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: PillSense groupExperimental treatment 1 intervention
Group B: Standard groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Discharge rate of patients with stable UGIB who can be triaged home safely after ED visit

To compare the percentage of patients who are safely discharged from ED visit with the usage of PillSense, compared to standard treatment.

Time frame
1.5 years

Secondary outcomes

1

Risk of clinical rebleeding after a negative PillSense reading

To measure the number of patients who have clinical re-bleeding in both arms.

Time frame
1.5 years
2

Discharge rate of patients who can be triaged home using PillSense , compared to conventional clinical scoring system like Glasgow Blatchford Score (GBS).

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.

Time frame
1.5 years
3

Number of inpatient beds saved from this arrangement

To review the beds and potential cost savings from the hospital from the reduction of admissions

Time frame
1.5 years
4

Risk of patient morbidity after a negative PillSense reading

To quantify and specify any patient morbidity after a negative PillSense reading.

Time frame
1.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tan Tock Seng Hospital

Lead sponsor

EnteraSense Limited

Collaborator

Source ClinicalTrials.gov
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