A Vanderbilt Institute for Surgery and Engineering (VISE) research team is conducting the first phase 1 clinical trial of a magnetic, flexible endoscope that has the potential to provide a safer alternative to standard colonoscopy, particularly for individuals with inflammatory bowel disease (IBD).
The in-human studies of a magnetically actuated robotic platform for colonoscopy developed by the group, including demonstration of intelligent control with assistive autonomy using magnetic fields, began this month at Vanderbilt University Medical Center.
Phase 1 clinical trials involve a small number of patients and are intended to assess the safety of the treatment. The investigative team received a four-year, $1.2 million National Institutes of Health grant to support their research.
IBD impacts the lives of more than 3 million people in the United States. It includes Crohn’s disease and ulcerative colitis, which are characterized by chronic inflammation of the gastrointestinal (GI) tract.
Prolonged inflammation results in damage, and patients with IBD are at increased risk for colorectal cancer. Because of this, it is recommended that patients with IBD have more frequent surveillance of their GI tract. This puts them at a much higher risk over a lifetime for colonoscopy-related complications when compared to individuals without IBD.
“Colonoscopies are an invaluable preventive screening test for colon cancer, but many individuals still avoid this procedure, whether out of fear, perceived discomfort or the potential risk of sedation,” said Keith Obstein, MD, MPH, principal investigator and professor of Medicine at VUMC and professor of Mechanical Engineering at Vanderbilt University. “These concerns are magnified for patients with IBD. Our goal in developing this tool is to make navigating the colon safer for patients and much easier for the clinician.”
The novel endoscope developed by the team contains a video camera and permanent magnet at the end of a tether and an external permanent magnet attached to a robotic arm. The endoscope, which is more compliant than conventional endoscopes used for colonoscopies, is guided through the colon by the magnetic coupling of the magnets.
The magnetic field generated, along with a localization algorithm, allows the system to know the exact position and orientation of the endoscope inside the body. Application of an autonomous control algorithm then allows the clinician to focus on finding, detecting and treating lesions while the system performs the movements requested by the clinician.
“The external magnet pulls the endoscope along instead of a physician pushing the colonoscope from behind as in traditional endoscopy,” said Obstein. “This eliminates much of the physical pressure that is typically placed on the patient’s colon, potentially reducing the need for sedation and avoiding adverse events.”
The phase 1 trial is a continuation of a VISE collaboration between Obstein and Pietro Valdastri, PhD, professor and chair in Robotics and Autonomous Systems at University of Leeds. Obstein and Valdastri run the Science and Technology of Robotics in Medicine (STORM) Lab USA and UK, respectively.
The team began work on this project 15 years ago. Since that time, the U.S. Preventive Services Task Force issued a new recommendation in 2021 that colorectal cancer screening for people at average risk should start five years sooner at age 45.
“Since the recommended age that people should begin screenings was lowered, there are many more colonoscopies that need to be done now,” Valdastri said. “We believe our technology can both increase capacity to provide these critical examinations and make these screenings pain free. It is very rewarding to now be at the point of our phase 1 trial.”
Vanderbilt University’s commitment to interdisciplinary work and the proximity of Vanderbilt University’s School of Medicine and Engineering School, as well as Vanderbilt University Medical Center, provides an ideal collaborative environment for advancing research and technology in this field. The Vanderbilt Institute for Surgery and Engineering provides a structure that facilitates this interdisciplinary work.
The research is supported by the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health under award number R01EB018992.