Aim of the ColCap application during routine colonoscopy: Colon and rectal cancer is a significant public health problem in economically developed western countries and Japan. Evidence-based medical data from professional endoscopic guidelines demonstrated that the morbidity and mortality of colorectal cancer could be significantly reduced by early detection and removal of colorectal polyps during a screening colonoscopy, especially by detecting and removing intestinal adenomas with endoscopic polypectomy that are considered precancerous. In screening colonoscopy population of patients over 50 years of age, the average polyp detection rate is around 40-50%. Most of these lesions are small and below 5 mm in size. Any technological development that can reduce the number of polyps overlooked or missed during colonic endoscopic screening and increase the polyp detection rate can improve the diagnostic efficiency of colonoscopy, thereby reducing the chances of developing a colon tumor between 5-year screening cycles (interval cancer). Any technological development suitable for increasing the detection rate of polyps below 5 mm will increase the cost-effectiveness of the endoscopic procedure and its tumor prevention potential. One such possibility is to increase the area of ​​the colon mucosal surface visibility by the endoscope utilizing a single-use plastic cap that can be attached to the distal end of the endoscope. The ColCap we developed is a plastic extension, a disposable medical endoscopic accessory device for colon examinations with any type of colonoscope (Fujifilm, Olympus, Pentax). ColCap is a mechanical plastic cap that can be pulled onto and attached to the end of the endoscope and has been developed, and tested for colonoscopy during in-vivo and in-vitro testing (pilot study), which increases the endoscope’s field of view and improves the recognition rate of small polyps. Reduction of polyp miss rate by enhancing the effectiveness of colonic mucosal reflection during colorectal screenings. Using our plastic cap (ColCap) also stabilizes the distance between the colonoscope optics and the polyp surface during image capturing, thereby assisting accurate optical documentation of colonoscopy examinations, and facilitating endoscopic removal of the polyps.

The indication to use: Disposable, replaceable, endoscope-mounted medical device, the application of which is indicated in all colonoscopy examinations, especially for CRC screening.

Protocol for everyday application: During a screening colonoscopy, the endoscopic assistant attaches the disposable COLCAP TM device to the end of the colonoscope. The device does not impede the progression of the colonoscope into the cecum since the wings are relatively closed to the shaft. However, during the withdrawal (pulling back) phase, the COLCAP device wings can fully open and help to detect the polypoid lesions in the colonic surface by smoothing the colonic folds and increasing the field of view of the colonoscope.

Benchmarking: The basic idea of ​​the unique tool we have developed comes from nature, and as the competing products increase the field of view and explore with needle-like cylinders, our product (also with a solution taken from nature) provides better examination without any damage of the colonic mucosa with flower-like petals and helps the camera lens to optimize the field of view. As long as our competitors’ solutions are similar to pine, our product is a system of technical wings that can best resemble the petals of a freesia flower. Competitor products that are already available on the market might have similar functionality, but due to the listed disadvantages, they have not become widespread use. Due to their unfavorable design, the frontal part of competing products currently available on the market can also cause colonic irritation or injury and may interfere with the colonoscope maneuverability.