RecruitingOBSERVATIONAL

Video Capsule Endoscopy for Detection of Gastrointestinal Bleeding in the Small Bowel

This research is investigating how effective a special camera pill, known as a capsule endoscopy, is at finding the source of bleeding in the small bowel. When someone has bleeding from their gut that isn't found during a gastroscopy or colonoscopy, this tiny camera pill can help. The study wants to see how often the capsule finds the bleeding, and whether finding it sooner (within two days) leads to better ways of treating it. Researchers are looking at both past patient information and new patients to understand if earlier detection and treatment mean less bleeding in the future. They are also checking for any issues found like growths or inflammation.

At a glance

Status

Recruiting

Sponsor

University Hospital Freiburg

Enrolment target

1,300

Start

01 Sep 2023

Estimated completion

15 Jul 2028

GastroIntestinal Bleeding

What is this study about?

Imagine you have bleeding from your gut, but doctors can't find where it's coming from using common tests like a gastroscopy (looking into your stomach) or a colonoscopy (looking into your large bowel). This can be worrying and frustrating. That's where a "capsule endoscopy" comes in. This isn't a typical operation; instead, you swallow a small capsule, about the size of a large vitamin pill, which contains a tiny camera. As it travels through your small bowel, it takes pictures, which doctors can then review to find the source of the bleeding.

This study is looking at how good this camera pill is at spotting these hidden bleeds. Doctors already know that if they can do this test quickly, ideally within two days of the bleeding, they are much more likely to find what's causing the problem. They also want to see what kinds of things are causing the bleeding, such as small growths, damaged blood vessels, or inflammation. Another important part of the study is looking at how quickly treatments can be given once the bleeding is found.

The researchers are studying two groups of people: some who have had this camera pill in the past and new patients who will have it as part of this study. This helps them compare results over time and understand if new recommendations for earlier testing are making a real difference. Ultimately, they hope to improve how doctors find and treat bleeding in the small bowel, leading to better outcomes and fewer bleeding episodes for patients.

Key takeaways

This study investigates a camera pill (capsule endoscopy) for finding gut bleeding.
It focuses on bleeding that other tests haven't been able to find.
The study aims to see if finding bleeding sooner leads to better patient outcomes.
Both past and new patients' information is being used to understand the benefits.
It will help improve how we diagnose and treat small bowel bleeding.

Who may be eligible?

This study is for adults aged 18 or older. You might be able to take part if you have signs of bleeding in your gut that doctors suspect is coming from your small bowel, and if other tests like a gastroscopy and colonoscopy haven't found the problem.

Before joining, you'll need to give your full permission, known as informed consent, meaning you understand what the study involves and agree to take part.

You won't be able to join if there are reasons why you shouldn't have a capsule endoscopy. For example, if you have any narrowing or blockages in your gut, the capsule might get stuck, so this test wouldn't be safe for you.

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 18 years old or older?
Do you have signs of bleeding from your gut that doctors suspect is from your small bowel?
Have your gastroscopy (stomach scope) and colonoscopy (large bowel scope) not found the cause of bleeding?
Are there no reasons why a camera pill might get stuck in your gut (like blockages or narrowing)?
Are you able to provide your full consent to participate?

Answer every question to see your result.

What does participation involve?

This study involves undergoing a capsule endoscopy. You would swallow a small camera pill, which then takes pictures as it travels through your digestive system. You'll wear a small recorder on your waist that collects these images. You can usually go about your normal daily activities while the capsule is working. After a set time, you'll return the recorder to the clinic. Doctors will then review the images to look for any bleeding or other issues in your small bowel. The capsule passes naturally with a bowel movement. If bleeding is found, further procedures, such as another type of endoscopy (enteroscopy) to treat the bleeding, might be discussed. The study will track any treatments given and whether you experience further bleeding episodes. The total duration of your active participation would involve the capsule endoscopy procedure and potential follow-up, which would be explained fully by the study team.

Potential risks and benefits

Taking part in this study may help doctors better understand and treat small bowel bleeding, potentially leading to faster diagnosis and more effective treatment options for people like you in the future. The main potential risk of a capsule endoscopy is the camera getting stuck in a narrowed part of the bowel, which might require a procedure to remove it, though this is rare. You will be monitored closely, and the healthcare team will explain all potential risks in detail. Remember, choosing to participate is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

University Medical Center Freiburg, Department of Medicine II
Verified postcode
Freiburg im Breisgau, Germany· Recruiting

Common questions

What is a capsule endoscopy?

It's a tiny camera inside a pill that you swallow. It takes pictures as it travels through your small bowel to look for bleeding or other problems.

Why is this study important?

It helps doctors understand how well the camera pill finds hidden bleeding and if finding it quickly leads to better treatments and fewer repeated issues for patients.

Will I feel anything during the capsule endoscopy?

Most people don't feel the capsule as it passes through their digestive system. You might wear a small recording device on your waist.

What happens if they find bleeding?

If bleeding is detected, your doctors will discuss further treatment options with you, which might include another type of procedure to address the bleeding directly.

Can I stop participating at any time?

Yes, you are free to leave the study at any point without it affecting your medical care.

How to find out more

Michael Schultheiss, MD

michael.schultheiss@uniklinik-freiburg.de +49761/270-34010 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.