Using a swallowable blood detection capsule to help triage patients presenting with symptoms of an upper gastrointestinal bleed
This study explores if a small, swallowable capsule, PillSense, can improve how doctors manage patients with suspected bleeding from their upper gut (gullet, stomach, and early small bowel). Currently, everyone with moderate to high risk of bleeding stays in hospital for tests like an endoscopy (a camera test). PillSense quickly detects blood, helping doctors decide if it's safe for some patients to go home and have their camera test later, freeing up hospital beds. If you join, you might get standard hospital care or swallow the PillSense capsule. The study then checks how you recover. This research aims to make patient care more efficient and potentially allow some people to recover at home sooner.
At a glance
What is this study about?
When you come to the hospital with symptoms that suggest bleeding in your upper gut, like vomiting what looks like coffee grounds or black, tarry stools, doctors need to find out why. Currently, everyone suspected of having significant bleeding is usually admitted to the hospital for tests, including an endoscopy. An endoscopy is a procedure where a doctor uses a thin, flexible tube with a camera on the end, gently passed down your throat while you're sedated, to look closely at your gullet, stomach, and the first part of your small bowel. This camera test helps them find the source of any bleeding and decide on the best treatment.
This study is looking at a new device called PillSense, which is a small capsule you swallow. Think of it like a vitamin pill, but it has a tiny sensor inside. Once swallowed, it quickly checks for blood in your upper gut and sends a signal to a small receiver held near you, telling your doctors within minutes if blood is detected or not. The main goal of this study is to see if using PillSense can help doctors make a quick and safe decision about your care. Can you go home and have your endoscopy as an outpatient in the next few days, or do you need to stay in the hospital for urgent tests and treatment?
By helping doctors sort patients more effectively, PillSense could potentially mean that those who are at low risk according to the capsule test might avoid an overnight hospital stay and have their camera test scheduled for a slightly later date. This could make things more comfortable for patients and help hospitals manage their resources better. The study will carefully compare this new approach with the current standard care to ensure it's safe and effective.
Key takeaways
- PillSense is a swallowable capsule that detects blood in the upper gut.
- It aims to help doctors quickly decide if you need urgent hospital care or can have an endoscopy later.
- Participation involves being randomly assigned to standard care or the PillSense group.
- Potential benefits include quicker decisions and possibly avoiding an overnight hospital stay.
- Main risks are rare and include the capsule not passing, requiring removal.
- Your safety is a top priority, and you can withdraw from the study at any time.
Who may be eligible?
This study is looking for adults aged between 18 and 84 who come to a hospital emergency department with signs of acute bleeding from their upper gut. This could include symptoms like vomiting what looks like coffee grounds or having black, tarry stools. To be considered, doctors will use a scoring system to assess your risk, and you'd need to fall into a specific 'moderate-risk' category.
There are certain situations that would mean you can't take part. For example, if you are very unwell with significantly low blood pressure or a very fast heart rate, or if doctors decide you need immediate intensive care or surgery. You also can't participate if you are actively vomiting fresh blood, or if you need a blood transfusion. We also can't include you if you have certain existing conditions that might make swallowing the capsule unsafe, such as problems with swallowing, a history of bowel blockages, or recent stomach surgery. If you're pregnant, breastfeeding, or have certain medical implants (like a heart pacemaker), you wouldn't be suitable either.
Essentially, the study aims to include people who are stable enough to consider alternatives to immediate hospital admission, but who still have symptoms that suggest a potential upper gut bleed that needs investigating.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 84 years old?
- Are you experiencing symptoms like coffee ground vomit or black, tarry stools?
- Are you stable enough, with no low blood pressure or very fast heart rate, and not needing an immediate blood transfusion?
- Do you have no known issues with swallowing or bowel blockages?
- Are you not pregnant or breastfeeding, and do you not have an electrical implant like a pacemaker?
What does participation involve?
If you decide to take part, a research team member will explain everything and answer your questions, even showing you a video of how PillSense works. If you agree, you'll sign a consent form. We'll then ask about your symptoms, medical history, and medicines to make sure the study is right for you. Once confirmed, a computer will randomly place you into one of two groups, much like flipping a coin.
If you're in the 'standard care' group, you'll be admitted to the hospital and receive the usual tests and endoscopy given to all patients with suspected upper gut bleeding in the UK. The research team will track your hospital visit and call you after 7, 14, and 30 days to check how you're doing.
If you're in the 'PillSense' group, you'll swallow the capsule with guidance from the team. Within 5-10 minutes, a small device will show if blood is detected or not. Your doctors, using this result along with your symptoms, examination, and other tests, will decide if you can go home for an outpatient endoscopy within 3-5 days, or if you need to stay for urgent care. Your safety is always paramount; if your condition changes or worsens, you should contact the research team or, in an emergency, call 999. In this group, we'll also call you at 7, 14, and 30 days. You'll need to check your stools to see if the capsule has passed naturally. If you haven't seen it, we'll arrange an X-ray to confirm it's passed or locate it.
Potential risks and benefits
Locations (2)
- University College London Hospitals NHS Foundation TrustUnverifiedLondon, England
- SouthamptonUnverifiedSouthampton, England
Common questions
What is an endoscopy?
An endoscopy is a common procedure where a doctor inserts a thin, flexible tube with a camera down your throat to look at your gullet, stomach, and the first part of your small intestine. This helps them find the cause of bleeding.
What is PillSense?
PillSense is a small, swallowable capsule that can quickly detect if there's blood in your upper gut. It sends a signal to a device nearby so doctors can make quick decisions about your care.
Will I know if I'm getting the PillSense capsule or standard care?
Yes, both you and the doctors will know which group you are in. This study is not 'blinded'.
What happens if I swallow the PillSense capsule and it doesn't pass?
If you don't see the capsule pass, you must tell the research team. They will arrange an X-ray to check its location. In rare cases, if it gets stuck, it might need to be removed.
Who is paying for this study?
The study is funded by Enterasense, the company that makes the PillSense capsule.
How to find out more
Benjamin Norton
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.