Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE) in Participants With Inflammatory Bowel Disease (IBD)
NCT06989424 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2026-04-21
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.
Conditions
- Inflammatory Bowel Disease (IBD)
- Colonoscopy
Interventions
- DEVICE
-
Magnetic 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.
Sponsors & Collaborators
-
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
collaborator NIH -
Vanderbilt University Medical Center
lead OTHER
Principal Investigators
-
Keith L Obstein · Vanderbilt University Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2026-12-31
- Completion
- 2027-01-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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