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

Starting soon · Not applicable

Conditions studied: Inflammatory Bowel Disease (IBD), Colonoscopy

In brief

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 facts

Study ID

NCT06989424

Run by

Vanderbilt University Medical Center

People needed

6

Starts

2026-07-01

Expected to finish

2027-01-01

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 females of childbearing potential will undergo either urine or blood pregnancy testing.
• Cancer positive subjects or any patients currently undergoing any treatment or therapy to treat, cure, or mitigate cancer.
• Symptoms consistent with coronavirus (COVID-19) --- pyrexia, new persistent cough, or anosmia --- or a positive coronavirus (COVID-19) polymerase chain reaction (PCR) swab result
• Previous incomplete or failed colonoscopy
• Colonic resection
• Severe diverticulosis
• Known or suspected colonic stricture
• Previous radiation therapy to the abdomen or pelvis
• Actively flaring inflammatory bowel condition (e.g. active flare of IBD or diverticulitis)
• Known or suspected bowel obstruction
• Presence of ascites
• Participants taking anticoagulant medications or antiplatelet therapy (excluding aspirin) within the last 3 days
• Known coagulation disorder (INR ≥ 1.5 or platelets < 150 x 109)
• Known to have phenylketonuria or Glucose-6-Phosphate-Dehydrogenase (G6PD) deficiency
• Abdominal surgery within the last 6 months
• Drug or alcohol abuse

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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