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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Magnetic Flexible Endoscope (MFE) to evaluate its movement through the colon of individuals with Inflammatory Bowel Disease (IBD), such as Ulcerative Colitis or Crohn's Disease. The MFE consists of a thin tube with a camera, light, and magnet at the tip, guided through the colon by a robotic arm. The study aims to determine if the MFE is easy to use and comfortable for patients. Individuals with stable IBD who are not experiencing flare-ups might be suitable candidates for this trial. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future diagnostic procedures.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have taken anticoagulant or antiplatelet medications (except aspirin) in the last 3 days.

What prior data suggests that the Magnetic Flexible Endoscope is safe for use in patients with Inflammatory Bowel Disease?

Research has shown that the Magnetic Flexible Endoscope (MFE) has been tested in people without causing problems or discomfort. In earlier studies, the MFE moved smoothly through the colon. This endoscope is unique because a magnet at its tip is guided by another magnet on a robotic arm outside the body. This design aids its easy movement through the colon. So far, the MFE has been well-received, demonstrating promising safety results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Magnetic Flexible Endoscope (MFE) because it offers a new approach to examining the colon in patients with inflammatory bowel disease (IBD) and those needing colorectal cancer screening. Unlike the standard colonoscopy, which uses a rigid tube, the MFE is more flexible and uses magnetic guidance, potentially making the procedure more comfortable and less invasive for patients. This innovative method could improve visualization and access during the procedure, providing a clearer view and possibly better diagnostic accuracy. The hope is that the MFE could enhance patient experience and outcomes, making it a promising advancement in the field.

What evidence suggests that the Magnetic Flexible Endoscope is effective for Inflammatory Bowel Disease?

Research shows that the Magnetic Flexible Endoscope (MFE) holds promise for safely exploring the colon. Earlier studies found that it could navigate the colon without causing harm or discomfort. The MFE uses magnets, making it easier to guide than traditional scopes. This trial will compare two approaches: one group will undergo their standard of care (SOC) colonoscopy followed by the MFE, while the other group will have a colonoscopy with the MFE followed by the SOC colonoscopy. This new method could help detect early signs of colorectal cancer, potentially improving patient health. Although more research is needed, early results are encouraging for people with Inflammatory Bowel Disease (IBD) considering this new technique. ^{1 2 3 4 6}

Who Is on the Research Team?

Keith L Obstein

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06989424

Study Details | NCT06989424 | Visualization of the Colon ... In this study, the investigators will test the ability of the Magnetic Flexible Endoscope (MFE) to travel through the colon of people with Inflammatory ...

2. journals.lww.com journals.lww.com/ajg/fulltext/9900/the_magnetic_flexible_endoscope__phase_1.1792.aspx

The Magnetic Flexible Endoscope: Phase 1 First-in-Human... In addition, early detection of colorectal cancer is associated with significantly better outcomes including the opportunity for endoscopic cure ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7834699/

Magnetic flexible endoscope for colonoscopy - PubMed Central Both detection of early-stage CRC and removal of adenomatous polyps during colonoscopy have been shown to reduce CRC mortality . Additional ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05833789

Visualization of the Colon Through Use of the Magnetic ... In this study, the investigators will evaluate the ability of the Magnetic Flexible Endoscope (MFE) to travel through the human colon. The MFE is a device ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40493042/

The Magnetic Flexible Endoscope: Phase 1 First-in-Human ... The MFE successfully traversed the human colon without adverse event or patient discomfort. System performance was successful without ...

6. app.dimensions.ai app.dimensions.ai/details/grant/grant.3803193

A magnetic capsule endoscope for colonoscopy in patients ... The main risks of CLS are related to procedural sedation, patient discomfort, or perforation of the colon from looping. Looping and mesenteric stretching occur ...