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

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · May 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Magnetic Flexible Endoscope (MFE), which is designed to help doctors see inside the colon of patients with Inflammatory Bowel Disease (IBD). The MFE is a thin, flexible tube with a tiny camera and light at the end, about the size of a penny. It can be moved through the colon using a magnet controlled by a robotic arm outside the body. The goal of the study is to understand how well the MFE can navigate through the colon and whether patients find the experience comfortable.

To participate in the trial, individuals need to be between 18 and 70 years old and have stable IBD, meaning their condition is not currently flaring up. They should also not have any serious medical issues or certain other conditions that could complicate the study. Participants can expect to undergo a procedure where this new device is used to visualize their colon. The trial is not yet recruiting participants, but it aims to gather important information about this innovative technology for patients with IBD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• Exclusion Criteria:
• • 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