PRIORITISE Version 1.0
Research type
Research Study
Full title
Pillsense system for the RIsk stratification Of suspected upper gastRointestinal bleeding to Improve the Triage of patIentS at modErate-risk: a randomised controlled trial (PRIORITISE)
IRAS ID
365163
Contact name
Chiara Di Carlo
Contact email
Sponsor organisation
EnteraSense Ltd.
ISRCTN Number
ISRCTN12586238
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Bleeding from the stomach or upper gut is a common medical emergency that requires
people to attend Accident & Emergency. Based on initial tests, doctors decide whether
someone needs to stay in hospital for an urgent camera test, known as endoscopy,
that looks in the stomach. During the endoscopy doctors may find the cause of
bleeding, but in over one-third of cases, no bleeding is found because it has already
stopped, or the symptoms had another cause. Doctors only really know if it is safe to
go home once the endoscopy has been completed, or they calculate a score that
determines a person’s risk without emergency treatment. This risk is divided into low,
moderate and high. This study is testing whether a small swallowable capsule, called
PillSense, can quickly check for blood in upper gut within 10 minutes. The aim is to
see whether PillSense can help doctors make quicker decisions and avoid
unnecessary admissions to hospital for patients. Adult patients who present with
symptoms of bleeding without major problems will be invited to swallow the PillSense
capsule if they are at moderate risk. Patients who consent to take part will be randomly allocated to one of two groups. The first group will use the PillSense capsule the second group will be given usual NHS care, which is admission to a ward for an inpatient endoscopy. If PillSense says “No blood detected”, and the clinical teams agrees it is safe, patients will go home and return for an outpatient endoscopy within five days. If PillSense says “Blood detected”, patients are admitted for earlier tests and treatment. Patients will have a follow-up phone call at 7-, 14-, and 30-days after discharge to check how they are, and if they received PillSense, confirm it has passed.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
25/NW/0366
Date of REC Opinion
11 Mar 2026
REC opinion
Further Information Favourable Opinion