PillSense for Suspected Upper Gastrointestinal Bleeding

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 Rec

Первичные конечные точки

• Discharge rate of patients with stable UGIB who can be triaged home safely after ED visit [Срок оценки: 1.5 years]

Вторичные конечные точки (5)

• Risk of clinical rebleeding after a negative PillSense reading [Срок оценки: 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). [Срок оценки: 1.5 years]
• Number of inpatient beds saved from this arrangement [Срок оценки: 1.5 years]
• Risk of patient morbidity after a negative PillSense reading [Срок оценки: 1.5 years]
• Risk of patient mortality after a negative PillSense reading [Срок оценки: 1.5 years]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Сингапур · 1 центр

• Tan Tock Seng Hospital — Singapore

Публикации

• Gleeson F, Clarke E, Lennon J, MacMathuna R, Crowe J. Outcome of accident and emergency room triaged patients with low risk non-variceal upper gastrointestinal haemorrhage. Ir Med J. 2006 Apr;99(4):114-7. PMID 16972584
• Owensby S, Taylor K, Wilkins T. Diagnosis and management of upper gastrointestinal bleeding in children. J Am Board Fam Med. 2015 Jan-Feb;28(1):134-45. doi: 10.3122/jabfm.2015.01.140153. PMID 25567834
• Biecker E, Heller J, Schmitz V, Lammert F, Sauerbruch T. Diagnosis and management of upper gastrointestinal bleeding. Dtsch Arztebl Int. 2008 Feb;105(5):85-94. doi: 10.3238/arztebl.2008.0085. Epub 2008 Feb 1. PMID 19633792
• Ferguson CB, Mitchell RM. Non-variceal upper gastrointestinal bleeding. Ulster Med J. 2006 Jan;75(1):32-9. No abstract available. PMID 16457402
• Rockall TA, Logan RF, Devlin HB, Northfield TC. Incidence of and mortality from acute upper gastrointestinal haemorrhage in the United Kingdom. Steering Committee and members of the National Audit of Acute Upper Gastrointestinal Haemorrhage. BMJ. 1995 Jul 22;311(6999):222-6. doi: 10.1136/bmj.311.6999.222. PMID 7627034
• Rockall TA, Logan RF, Devlin HB, Northfield TC. Risk assessment after acute upper gastrointestinal haemorrhage. Gut. 1996 Mar;38(3):316-21. doi: 10.1136/gut.38.3.316. PMID 8675081
• Zimmerman J, Meroz Y, Arnon R, Tsvang E, Siguencia J. Predictors of mortality in hospitalized patients with secondary upper gastrointestinal haemorrhage. J Intern Med. 1995 Mar;237(3):331-7. doi: 10.1111/j.1365-2796.1995.tb01183.x. PMID 7891055
• Schembre DB, Ely RE, Connolly JM, Padhya KT, Sharda R, Brandabur JJ. Semiautomated Glasgow-Blatchford Bleeding Score helps direct bed placement for patients with upper gastrointestinal bleeding. BMJ Open Gastroenterol. 2020 Nov;7(1):e000479. doi: 10.1136/bmjgast-2020-000479. PMID 33214231

Идентификаторы

NCT: NCT06500468 · 2024/00060

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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