Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE) in Participants With Inflammatory Bowel Disease (IBD)
Vanderbilt University Medical Center
Summary
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.
Description
Colonoscopy is the gold standard for making the diagnosis, following clinical response, establishing prognosis, and creation of management plans for patients with Inflammatory Bowel Disease (IBD). While colonoscopy is a relatively safe procedure, there are several limitations due to the unintuitive drive mechanism and mechanical design of current conventional colonoscopes. Additionally, for patients with IBD, the procedure is associated with a higher lifetime risk of adverse event due to increased frequency of examination-more than a 6-fold increased risk when compared to their non-IBD counter…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Abdominal circumference \< 96 cm * Stable, non-flaring inflammatory bowel disease (e.g. Ulcerative Colitis and Crohn's Disease) Exclusion Criteria: * 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 fema…
Interventions
- DeviceMagnetic Flexible Endoscope (MFE)
The 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.
Location
- Vanderbilt University Medical CenterNashville, Tennessee