Magnetic Flexible Endoscope for Inflammatory Bowel Disease

Overseen By Amy Motley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Cancer, Pregnancy, COVID-19, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

6 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Keith L Obstein

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for individuals with Inflammatory Bowel Disease (IBD) who are interested in a new colon examination method. Specific eligibility criteria aren't provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

Able to provide written informed consent

American Society of Anesthesiologists (ASA) class < 3

Abdominal circumference < 96 cm

Exclusion Criteria

I have phenylketonuria or G6PD deficiency.

Patients who do not meet inclusion criteria

Magnetic implants and wearable devices (such as insulin pumps)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo colonoscopy using the Magnetic Flexible Endoscope (MFE) and standard of care colonoscopy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and tolerability after the procedure

1-2 weeks

Treatment Details

Interventions

• Magnetic Flexible Endoscope (MFE)

Trial Overview The Magnetic Flexible Endoscope (MFE), which uses a magnetically-guided camera to visualize the colon, is being tested for its ability to navigate through the colons of IBD patients and assess its comfort level during use.

Participant Groups

Group I: Standard of Care (SOC) colonoscopy followed by Magnetic Flexible Endoscope (MFE) Experimental Treatment 1 Intervention

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.

Group II: Colonoscopy with Magnetic Flexible Endoscope (MFE) followed by Standard of Care (SOC) colonoscopy Experimental Treatment 1 Intervention

Patients in this group will have colonoscopy with the MFE followed by the legacy colonoscope for standard of care IBD/colorectal cancer screening.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+