The ColoCap study is an exciting research study funded by the NIHR. Its primary objective is to determine the diagnostic accuracy of Colon Capsule Endoscopy compared to colonoscopy. The ColoCap study consists of three workstreams.  

 In Work Stream 1 we shall perform a paired (back-to-back) study. Each participant will swallow the CCE and then, where possible, later in the same day they will have a colonoscopy. The study has been designed in collaboration with our Patient Advisory Group and as closely mirrors standard care as is possible. Over a two-year period, 973 participants will be recruited from three representative clinical contexts; suspected colorectal cancer, suspected inflammatory bowel disease and 3 yearly post-polypectomy surveillance. The study aims to recruit 973 patients over a 2-year period. 

 Within Work Stream 1, a Study Within A Trial and a nested sub-study of intra- and inter-reader agreement will be undertaken.  

 Work Stream 2 will develop models of cost-effectiveness.  

 Work Stream 3 involves a qualitative interview-based evaluation of patient and clinician experience of colon capsule endoscopy compared to colonoscopy, with reference to acceptability and choice.  

Patients are who are over the age of 18 who are being investigated by colonoscopy due to suspected colorectal cancer, suspected inflammatory bowel disease or who are on 3 yearly post-polypectomy surveillance will be eligible to participate. 

Patients will be asked to have a colon capsule endoscopy in the morning before their standard of care colonoscopy. Participants will receive a £100 voucher for their participation. 

Patients will have the option to consent to taking part in interviewers through the University of York to discuss their experience. 35 participants will be invited to the interviews and will receive a £30 voucher for participating. 

The ColoCap study is scheduled to recruit between 1st January 2025 – 31st December 2026.  

 We plan to run the study in 30 hospitals in England, Wales, and Scotland.  

This study is being sponsored by York and Scarborough Teaching Hospitals. The study is being organised by a research team from York & Scarborough Teaching Hospitals and the Centre for Healthcare Randomised Trials at the University of Aberdeen (CHaRT) and the Centre for Trials Research (CTR) at Cardiff University. 

ColoCap Expression of Interest Form - For sites

To express an interest in the study, please complete the attached expression of interest form and return to yhs-tr.colocapstudy@nhs.net 

ColoCap Expression of Interest Form V1.0