Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE) in Participants With Inflammatory Bowel Disease (IBD)
Not applicable · Testing Magnetic Flexible Endoscope (MFE) · 1 site · Vanderbilt University Medical Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Magnetic Flexible Endoscope (MFE) (a device) to check whether a device is practical to use. Condition(s) listed: Inflammatory Bowel Disease (IBD) and Colonoscopy.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- Male or female, 18 to 70 years of age
- Able to provide written informed consent
- American Society of Anesthesiologists (ASA) class < 3
Plus 3 more requirement(s). There are also 19 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 6 participants are expected to take part.
- Start date: 2026-12 (planned).
- Main results expected around 2028-07 (estimate from the record).
- 1 study site listed in United States.
Main thing being measured
- Feasibility to intubate the cecum (yes/no) (Day 1)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Disease (IBD); Colonoscopy |
| Lead sponsor | Vanderbilt University Medical Center |
| Collaborators | National Institute for Biomedical Imaging and Bioengineering (NIBIB) |
| Enrollment | 6 (estimated) |
| Start date | 2026-12 |
| Primary completion (est.) | 2028-07 |
| First posted | 2025-05-25 |
| Last updated | 2026-08-20 |
| Official title | Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE) in Participants With Inflammatory Bowel Disease (IBD) |
| ClinicalTrials.gov ID | NCT06989424 |
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.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center | Nashville, Tennessee | United States |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.