Active not recruitingOBSERVATIONAL

Extra Wide Field of View Lens Study

This study is investigating a new type of camera called a colonoscope, which is used to look inside your bowel. This special colonoscope offers doctors a wider view than standard equipment. The main aim is to see how well this new camera can find bowel growths, known as polyps, when used during a routine colonoscopy. Participants will have their colonoscopy as normal, either for a general check-up or to monitor polyps. We are simply observing how the new equipment performs in patients. There will also be one short follow-up phone call within two weeks of your procedure. This research helps us understand if new technologies can improve how we screen for and manage bowel problems.

At a glance

Status

Active not recruiting

Sponsor

Pentax Medical

Enrolment target

Start

21 Aug 2024

Estimated completion

30 Mar 2025

Colonic Polyp

What is this study about?

This study is looking at a new piece of medical equipment called a colonoscope. A colonoscope is a thin, flexible tube with a tiny camera on the end that doctors use to look inside your large bowel (colon). This new type of colonoscope has a special lens that allows the doctor to see a much wider area at one time than with current devices. The main purpose of this study is to observe whether this new, wide-view camera can effectively find small growths, called polyps, during routine colonoscopy procedures.

Finding polyps is very important because some types of polyps can, over many years, turn into bowel cancer. By finding and removing them early, we can help prevent cancer. Doctors already use colonoscopies to check for polyps and bowel cancer, or to keep an eye on people who have had polyps before. This study isn't testing a new treatment, but rather observing new technology to see if it can make these important checks even better.

We hope this study will give us valuable information about how this new colonoscope works in a real-world setting. If it proves to be effective, this could be a promising step towards improving how doctors examine the bowel, potentially making it easier to spot and remove polyps, and ultimately helping to prevent bowel cancer.

Key takeaways

Exploring a new colonoscope with a wider view for bowel exams.
Aims to see if the new camera can find bowel growths (polyps) effectively.
Participation involves a routine colonoscopy and one follow-up phone call.
Not a new treatment, but an observation of new medical technology.
Helps improve future bowel screening and polyp detection.
Risks are similar to a standard colonoscopy.

Who may be eligible?

To join this study, you would typically be having a routine colonoscopy for one of a few reasons: either as a check-up for bowel cancer if you're 50 or over, because of a positive stool test (a test that checks for hidden blood in your poo), or if you're having regular checks because you've had polyps before. You also need to be at least 18 years old and willing to sign a consent form that explains everything about the study.

There are some reasons why you might not be able to take part. For example, if you have certain serious health conditions, if you've already been told you have polyps that need to be removed, or if you have a known bowel disease like Crohn's disease or ulcerative colitis. If you've had major bowel surgery before, or have a very high risk of bowel cancer due to a genetic condition or many polyps, you also wouldn't be suitable.

We also can't include people who are pregnant or breastfeeding, those who might struggle to understand or follow the study instructions (perhaps due to language difficulties), or if you're already taking part in another medical study. You also need to be able to prepare properly for a colonoscopy, which involves taking special medicine to clear your bowel.

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 having a colonoscopy for a general check-up, a positive stool test, or to monitor previous polyps?
Are you 18 years old or older?
Are you able to prepare for a colonoscopy as usual?
Do you have any serious health conditions like severe heart or lung disease?
Are you pregnant or breastfeeding?
Are you currently taking part in another medical study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your experience will be very similar to a standard colonoscopy. You will undergo the usual preparation to clean your bowel. When you arrive for your procedure, the doctor will use the new colonoscope with the extra-wide view. The main difference is that we will be carefully observing how this new equipment performs during your routine check. Your colonoscopy will proceed as planned, whether it's for a general screening or to monitor existing polyps. After your colonoscopy, there will be one follow-up phone call from the study team. This call will take place within two weeks of your procedure and will primarily be to check how you are doing. The total duration of your direct involvement in the study, beyond your colonoscopy, will be limited to this single phone call.

Potential risks and benefits

The main benefit of taking part is contributing to medical research that could improve future colonoscopy procedures and help doctors find polyps more effectively. For you, the colonoscopy itself is still for your own health check-up, whether it's for screening or monitoring. The risks associated with this study are very similar to those of a standard colonoscopy, as we are simply observing a new camera. Colonoscopies carry small risks, such as discomfort, and very rarely, damage to the bowel. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

RKM 740 Interdisciplinary Care Clinic - Gastroenterology
Verified postcode
Düsseldorf, Germany

Common questions

What is a colonoscope?

It's a thin, flexible tube with a tiny camera on the end that doctors use to look inside your large bowel (colon).

What are polyps?

Polyps are small growths on the lining of your bowel. Some types can, over time, turn into bowel cancer, so finding and removing them is important.

Will this study involve extra procedures for me?

No, you will have your colonoscopy as planned. The only difference is that the doctor will use a new camera, and you'll have one follow-up phone call.

Is this a new treatment?

No, this is not a new treatment. It's a study looking at new equipment (a colonoscope) for finding polyps more effectively during a standard procedure.

What if I change my mind about taking part?

You can withdraw from the study at any time without giving a reason, and it won't affect your medical care.