We propose to develop, optimize, and pre-clinically assess a robotic platform that may provide a safer alternative to standard colonoscopy for patients with Inflammatory Bowel Disease (IBD). Patients with IBD are at increased risk for colorectal cancer and therefore surveillance has been recommended to occur at a shorter interval than that recommended for the general population. Therefore, over the course of an IBD patient's lifetime, they are subjected to a significantly larger number of colonoscopies than their non-IBD counterparts, resulting in a more than 6-fold increase in post-procedure adverse events. The main risks of colonoscopy are those related to procedural sedation, patient discomfort, or perforation of the colon from looping. Looping and mesenteric stretching occur due to the design of the colonoscope. Special maneuvers can be performed to minimize looping, making colonoscopy a procedure that requires a great degree of technical skill and experience to safely perform. Capsule endoscopy has already been extremely helpful for IBD patients, especially in the diagnosis of Crohn's disease in children and young adults. Adapting capsule endoscopy to colonoscopy as proposed by this project would allow for reduced risk of adverse events, thus providing great benefit to patients with IBD. By using the robotic platform we propose, the endoscopist will be able to remotely control the motion of a soft-tethered capsule to perform diagnosis and treatment at any location inside the human colon. Manipulation of the capsule is achieved by magnetic coupling, thanks to the interaction of two permanent magnets - one integrated inside the capsule and the other placed at the end effector of a robotic arm. Leveraging extensive preliminary results, with this study we will develop a fully vetted system ready for human clinical trials, and we will test the hypothesis that our approach has diagnostic and therapeutic capabilities comparable to standard colonoscopy, while at the same time, shortening the learning curve and decreasing both the degree of looping and mesenteric stretching. We will pursue these goals by (1) optimizing our robotic platform for human use, (2) implementing a safe, robust, and intuitive control, and (3) benchmarking the proposed technology with standard colonoscopy involving three different tiers. The Investigative Team, combining engineering and clinical faculty from Vanderbilt University, is uniquely positioned to achieve the success of this study. Specifically, the Investigators collectively possess expertise in endoscopic device design, clinical colonoscopy, assessment and validation of innovative gastrointestinal technologies, and translation of research-engineering developments into clinical applications. If successful, this approach will widen the implementation of IBD surveillance programs to rural areas thanks to the low cost of the platform (i.e., less than $20,000), ease of transport, no need for anesthesiologists or sedation monitors, and no need for specialized facilities within which examinations are performed.
The robotic platform we propose has the potential to provide a safer and potentially painless alternative to colonoscopy for patients with IBD. This has an impact on the life of more than one million Americans with ulcerative colitis or Crohn's disease. Long term, the proposed approach will widen the implementation of IBD surveillance programs to rural areas thanks to the low cost of the platform, ease of transport, no need for anesthesiologists or sedation monitors, and no need for specialized facilities within which examinations are performed.