Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE) in Participants With Inflammatory Bowel Disease (IBD)

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06989424
Status
Not Yet Recruiting

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Conditions

  • Colonoscopy
  • Inflammatory Bowel Disease (IBD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Magnetic Flexible Endoscope (MFE) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
6 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Standard of Care (SOC) colonoscopy followed by Magnetic Flexible Endoscope (MFE)
    Patients in this group will have their SOC colonoscopy for IBD/colorectal cancer screening completed with a legacy colonoscope followed by colonoscopy with the MFE.
  • Experimental: Colonoscopy with Magnetic Flexible Endoscope (MFE) followed by Standard of Care (SOC) colonoscopy
    Patients in this group will have colonoscopy with the MFE followed by the legacy colonoscope for standard of care IBD/colorectal cancer screening.

Primary Outcome Measure

Feasibility to intubate the cecum (yes/no) [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Michael G McGill
[email protected]
615-322-4643
Amy Motley
[email protected]
615-322-6281
Keith L Obstein (PRINCIPAL_INVESTIGATOR)

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By research site
Vanderbilt University Medical Center· Nashville, TN

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