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

NCT06989424 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: MFEIBD_2418945R01EB018992-08
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Disease (IBD); Colonoscopy

Keywords

Colonoscopy; Colon; Robotic; Magnetic; Endoscopy; Inflammatory Bowel Disease (IBD)

Outcome Measures

Primary Outcomes (1)

• Feasibility to intubate the cecum (yes/no)

  Ability to feasibly enter the cecum of the colon. Will be confirmed per standard endoscopic practice of visualizing and photo documenting at least 2 of the 3 common cecum landmarks (ileocecal valve, triradiate fold, appendiceal orifice).

  Day 1

Secondary Outcomes (3)

• Mucosal visibility

  Day 1

• Patient tolerance

  Day 1

• Endoscopist experience

  Day 1

Study Arms (2)

Standard of Care (SOC) colonoscopy followed by Magnetic Flexible Endoscope (MFE)

EXPERIMENTAL

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.

Device: Magnetic Flexible Endoscope (MFE)

Colonoscopy with Magnetic Flexible Endoscope (MFE) followed by Standard of Care (SOC) colonoscopy

EXPERIMENTAL

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

Device: Magnetic Flexible Endoscope (MFE)

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.

Colonoscopy with Magnetic Flexible Endoscope (MFE) followed by Standard of Care (SOC) colonoscopy; Standard of Care (SOC) colonoscopy followed by Magnetic Flexible Endoscope (MFE)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Keith L Obstein

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael G McGill

CONTACT

615-322-4643; michael.g.mcgill@vumc.org

Amy Motley

CONTACT

615-322-6281; amy.motley@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 25, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)