“I think it’s essential that people keep signing up to these type of trials to push research forward.”
A study looking at a device that may help to find polyps in the bowel (The ADENOMA study)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This is a study to see if a new device called Endocuff Vision makes it easier to find polyps during a colonoscopy.
More about this trial
Doctors can use a test called a colonoscopy to look inside the bowel to find polyps. When you have a colonoscopy, a thin, flexible tube with a camera at the end is passed into your back passage and up into your bowel. This is called a colonoscope.
The doctor or nurse doing the test (the colonoscopist) can see the polyps and remove them if necessary. Removing these growths reduces your risk of bowel cancer.
A new device called the Endocuff Vision can be attached to the end of the colonoscope to make it easier to see and remove polyps. It helps by holding back the folds of the bowel to give a clear view.
The aim of this study is to find out if using the Endocuff Vision will help colonoscopists to find more polyps. The study will also look at whether using the new device means the colonoscopies take longer or are more uncomfortable for the patient.
Who can enter
You may be able to join this study if all of the following apply. You
- Are going to have a colonoscopy at one of the hospitals taking part in the study
- Are at least 18 years old
You cannot join this study if any of these apply. You
- Can’t have a colonoscopy for any reason
- Have (or may have) a blockage in your bowel (this is known as bowel obstruction)
- Are known to have bowel cancer or conditions such as FAP or HNPCC
- Are known to have a narrowing of your bowel (a stricture)
- Have other bowel problems such a colitis,
Crohn’s diseaseor severe diverticular disease
- Are pregnant
- Take drugs such as clopidogrel or warfarin to stop blood clots forming
- Are having a colonoscopy as part of treatment for (or assessment of) a known problem
The researchers will ask 1,772 people to join this study. They will all have been referred for a colonoscopy at one of the 7 hospitals involved in the study.
This is a randomised study. You will be put into 1 of 2 groups by computer. Neither you nor the study team can decide which group you are in.
Half the people taking part will have a colonoscopy using the Endocuff Vision. The other half will have a colonoscopy as normal.
The study team will look at
- How long the colonoscopies take
- The number of adenomas found and removed from each person
They will record any drugs you have during the test and whether there are any problems.
The study team will ask you about any discomfort or pain you had during the colonoscopy. And they will give you a questionnaire to fill in the next day, asking about your experience of having this procedure. You can return this by post.
A member of the team may phone you about a month later to see how you are and ask if you’ve needed to go to hospital since having the colonoscopy.
The team will look at your medical notes to find the results of the colonoscopy. All the information the study team collect about you will be
Taking part in this study does not involve any extra hospital visits.
Attaching the Endocuff Vision to the end of the colonoscope slightly increases the width of the tube. This may make it more uncomfortable for a few seconds when the colonoscopist puts the tube into your back passage.
If the lower part of your bowel is particularly twisty or you have a condition where small pockets form in the wall of the bowel (diverticulosis), the colonoscope with the Endocuff Vision attached may not be able to pass through your bowel. In this situation, the colonoscopist will take the camera out of the bowel and remove the Endocuff Vision, before restarting the procedure.
There is a very small possibility that the Endocuff Vision becomes dislodged during the colonoscopy. If this happens, the colonoscopist would remove the Endocuff.
The Endocuff Vision may cause very minor grazes to the bowel wall. A study using an earlier version of the Endocuff showed these grazes in less than 1 in 3 people, and none caused any significant harm.
How to join a clinical trial
Professor Colin Rees
Professor Brian Saunders
ARC Medical Design Ltd
NIHR Clinical Research Network: Cancer
South Tyneside NHS Foundation Trust