In this study, the investigators will test the ability of the Magnetic Flexible Endoscope (MFE) to travel through the colon of people with Inflammatory Bowel Disease (IBD). The MFE is a device made of ultra-flexible tubing that contains a camera, light, and magnet at the tip. The tip of the tube is about the size of a penny. The magnet inside the tip allows the MFE to be moved through the colon by a second magnet attached to a robotic arm that is outside the body. The purpose of this study is to see how the MFE travels through the colon of IBD patients and if it is tolerable.
Male or female, 18 to 70 years of age
Able to provide written informed consent
American Society of Anesthesiologists (ASA) class < 3
No significant medical problems
Patients who do not meet inclusion criteria
Patients who are unable or unwilling to provide informed consent
Magnetic implants and wearable devices (such as insulin pumps)
Females who are pregnant. As part of routine pre-operative care, all females of childbearing potential will undergo either urine or blood pregnancy testing.
Crossover
Magnetic Flexible Endoscope (MFE)
DeviceThe Magnetic Flexible Endoscope (MFE) is a single-use endoscope intended to integrate with other commercially available devices for visualization of the human colon in order to eliminate the need for passage of the much stiffer, non-intuitive, risk prone standard colonoscope. The MFE will be introduced into the colon and traverse from the rectum to the cecum.
Feasibility to intubate the cecum (yes/no)
Ability to feasibly enter the cecum of the colon. Will be confirmed per standard endoscopic practice of visualizing and photo documenting at least 2 of the 3 common cecum landmarks (ileocecal valve, triradiate fold, appendiceal orifice).
Mucosal visibility
Operator assessed score, the Colon Visualization Index, will be used. Scale ranges from 0 (poor) to 4 (excellent)
Patient tolerance
Pain perception will be assessed with a validated pain score (Wong-Baker FACES Pain Rating Scale) with 0 be no hurt to 10 hurts worst during a post-study structured interview.
Endoscopist experience
Usability of the platform in terms of task load for the endoscopist will be assessed using the standardized validated National Aeronautics and Space Administration (NASA) Task Load Index (TLX) based on a multidimensional construct of six sub-scales: mental demand, physical demand, temporal demand, performance, effort, and frustration level. The sub-scales range from 0 (very low) to 100 (very high): the exception is the sub-scale of performance, where 0 is perfect and 100 is failure.
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Vanderbilt University Medical Center
Lead sponsor
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
