Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE)
NCT05833789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2024-12-27
Summary
In this study, the investigators will evaluate the ability of the Magnetic Flexible Endoscope (MFE) to travel through the human colon. 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 objective of this feasibility study is to determine navigation of the colon and tolerability of the Magnetic Flexible Endoscope (MFE) traveling in the human colon.
Conditions
- Colonoscopy
Interventions
- DEVICE
-
Magnetic Flexible Endoscope (MFE)
After colonoscopy has been completed with the legacy 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 -
National Institutes of Health (NIH)
collaborator NIH -
Vanderbilt University Medical Center
lead OTHER
Principal Investigators
-
Keith L Obstein · Vanderbilt University Medical Center
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-12
- Primary Completion
- 2023-10-13
- Completion
- 2023-10-13
- FDA Device
- Yes
Countries
- United States
Study Locations
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