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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01EB018992-08 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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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.
Colonoscopy is the gold standard for making the diagnosis, following clinical response, establishing prognosis, and creation of management plans for patients with Inflammatory Bowel Disease (IBD). While colonoscopy is a relatively safe procedure, there are several limitations due to the unintuitive drive mechanism and mechanical design of current conventional colonoscopes. Additionally, for patients with IBD, the procedure is associated with a higher lifetime risk of adverse event due to increased frequency of examination-more than a 6-fold increased risk when compared to their non-IBD counterparts.
For these reasons, our team has developed a novel, highly compliant, Magnetic Flexible Endoscope (MFE) with the functionality of a conventional colonoscope (i.e. camera, therapeutic channel, irrigation, insufflation, illumination, lens cleaning). The MFE is driven by magnetic coupling of the endoscope head that contains an internal permanent magnet and a robotic arm that holds an external permanent magnet. This enables a "front-pull" actuation mechanism to eliminate the need for pushing a semi-rigid insertion tube for advancement. The forward drive mechanism thus prevents buckling of the insertion tube and avoids looping/colon wall stress. This reduces the risk of perforation and pain during the procedure to allow for less (if any) procedural sedation.
The Magnetic Flexible Endoscope (MFE) is a single-use endoscope intended to integrate with other commercially available devices for the visualization of a human colon in order to eliminate the need for passage of the much stiffer, non-intuitive, risk prone standard colonoscope. This study builds on the successful completion of the first-in-human feasibility study that demonstrated safety and tolerability in healthy patients who were already scheduled for their routine standard-of-care screening colonoscopy. In this secondary study, the MFE device will be inserted into the rectum via the anus and navigated through the colon to the cecum, using magnetic manipulation, in patients with stable, non-active, Inflammatory Bowel Disease (IBD) who are due for their IBD/colorectal cancer surveillance/screening colonoscopy exams.
The investigators plan to assess safety and tolerability of MFE navigation in the colon from the rectum to the cecum in patients with stable non-active IBD who are due for their IBD/Colorectal Cancer surveillance/screening colonoscopy exams. This will be a parallel study design in which three of six patients will have standard of care colonoscopy completed with monitored anesthesia care (MAC) first followed by MFE and three of six patients will undergo unsedated MFE first followed by standard of care colonoscopy completed with MAC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mucosal visibility | Operator assessed score, the Colon Visualization Index, will be used. Scale ranges from 0 (poor) to 4 (excellent) | Day 1 |
| Patient tolerance | Pain perception will be assessed with a validated pain score (Wong-Baker FACES Pain Rating Scale) with 0 be no hurt to 10 hurts worst during a post-study structured interview. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael G McGill | Contact | 615-322-4643 | michael.g.mcgill@vumc.org | |
| Amy Motley | Contact | 615-322-6281 | amy.motley@vumc.org |
| Name | Affiliation | Role |
|---|---|---|
| Keith L Obstein | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 23, 2025 | May 9, 2025 |
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| Day 1 |
| Endoscopist experience | Usability of the platform in terms of task load for the endoscopist will be assessed using the standardized validated National Aeronautics and Space Administration (NASA) Task Load Index (TLX) based on a multidimensional construct of six sub-scales: mental demand, physical demand, temporal demand, performance, effort, and frustration level. The sub-scales range from 0 (very low) to 100 (very high): the exception is the sub-scale of performance, where 0 is perfect and 100 is failure. | Day 1 |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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