Title: A robotic magnetic flexible endoscope for painless colorectal cancer diagnostic screening, surveillance and intervention
Funder: Cancer Research UK

Abstract: Background. Bowel cancer is found in the colon or rectum and is one of the commonest cancers in the UK. It has the third highest death rate. A test called a Colonoscopy is used to find abnormalities in the bowel. During a colonoscopy a bendy tube with a camera on the end is used to look inside the bowel, take photographs and collect tissue samples. These can be used to confirm if a patient has an illness or to show how well drugs are working. The number of colonoscopies carried out in the UK doubled between 2012 and 2017. This means that endoscopy units need to increase capacity. Colonoscopy is an invasive test which sometimes causes side effects such as pain, bleeding or a tears in the bowel. Patients who have frequent colonoscopies or elderly people with heart problems would benefit from safer pain free colonoscopy. In this project, we will develop, optimize and conduct a first in-human test study of our Magnetic Flexible Endoscope (MFE) robotic platform which may provide a safer and easier alternative to standard colonoscopy. Aims. The project has 2 goals: (1) Obtain ethical approval for starting first-in-human trials; (2) Assess safety, and acceptability of the MFE in IBD patients. Methods. With CRUK support, we will make MFE prototypes for clinical use, test them and obtain ethical approval for first-in-human trials. We will talk to IBD patients who are having a colonoscopy and their doctors to help design our trial protocol. We will do two human trials at the Leeds Teaching Hospitals NHS Trust which will be with the supported by the NIHR Leeds Clinical Research Facility. The first trial will enroll 5 healthy patients who will be having a colonoscopy. The second trial will test the MFE in 12 IBD patients. We will compare performance of the MFE with normal colonoscopy and look at pain levels and acceptability to patients. How the results of this research will be used. Results will be used to find out how well the MFE works in human colons. We will also find out what patients and their doctors think about the new test. We are interested in sedation usage, pain, side effects and how quickly patients can return to their normal day to day life after a colonoscopy. In the future we would like to use the MFE in a wider group of patients.

Lay abstract: Background. Bowel cancer is found in the colon or rectum and is one of the commonest cancers in the UK. It has the third highest death rate. A test called a Colonoscopy is used to find abnormalities in the bowel. During a colonoscopy a bendy tube with a camera on the end is used to look inside the bowel, take photographs and collect tissue samples. These can be used to confirm if a patient has an illness or to show how well drugs are working. The number of colonoscopies carried out in the UK doubled between 2012 and 2017. This means that endoscopy units need to increase capacity. Colonoscopy is an invasive test which sometimes causes side effects such as pain, bleeding or a tears in the bowel. Patients who have frequent colonoscopies or elderly people with heart problems would benefit from safer pain free colonoscopy. In this project, we will develop, optimize and conduct a first in-human test study of our Magnetic Flexible Endoscope (MFE) robotic platform which may provide a safer and easier alternative to standard colonoscopy. Aims. The project has 2 goals: (1) Obtain ethical approval for starting first-in-human trials; (2) Assess safety, and acceptability of the MFE in IBD patients. Methods. With CRUK support, we will make MFE prototypes for clinical use, test them and obtain ethical approval for first-in-human trials. We will talk to IBD patients who are having a colonoscopy and their doctors to help design our trial protocol. We will do two human trials at the Leeds Teaching Hospitals NHS Trust which will be with the supported by the NIHR Leeds Clinical Research Facility. The first trial will enroll 5 healthy patients who will be having a colonoscopy. The second trial will test the MFE in 12 IBD patients. We will compare performance of the MFE with normal colonoscopy and look at pain levels and acceptability to patients. How the results of this research will be used. Results will be used to find out how well the MFE works in human colons. We will also find out what patients and their doctors think about the new test. We are interested in sedation usage, pain, side effects and how quickly patients can return to their normal day to day life after a colonoscopy. In the future we would like to use the MFE in a wider group of patients.

Research activity codes: 4.4 POPULATION SCREENING
Health categories: CANCER AND NEOPLASMS