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Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE)
NA trial testing Magnetic Flexible Endoscope (MFE) in Colonoscopy in 5 participants. Completed in 13 October 2023.
| Lead sponsor | Vanderbilt University Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 5 |
| Start date | 12 October 2023 |
| Primary completion | 13 October 2023 |
| Estimated completion | 13 October 2023 |
| Sites | 1 location across United States |
Vanderbilt University Medical Center
Adults 18 to 70, any sex, with Colonoscopy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participants with successful MFE navigation to the cecum from the rectum of the colon in less than 40 minutes
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy for Colorectal Cancer Screening | 0 |
Number of reported non-tolerability events, including events associated with the product's administration affecting the ability or desire of the patient to adhere to the intensity of therapy. Tolerability was assessed through qualitative interview post procedure.
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy for Colorectal Cancer Screening | 0 |
The NASA Task Load Index (TLX) is a validated assessment instrument (Ames Research Center, Moffett Field, CA, USA) to assess perceived workload 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.
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy for Colorectal Cancer Screening | 31 | 28 – 33 |
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy for Colorectal Cancer Screening | 44 | 29 – 47 |
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy for Colorectal Cancer Screening | 28 | 25 – 31 |
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy for Colorectal Cancer Screening | 47 | 46 – 47 |
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy for Colorectal Cancer Screening | 36 | 29 – 45 |
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy for Colorectal Cancer Screening | 40 | 32 – 45 |
Colon mucosal visibility scale is an operator assessed cumulative score utilizing the colon visualization index which has a score range of 0-4, where 0 is poor and 4 is excellent.
| Group | Value | 95% CI |
|---|---|---|
| Colonoscopy for Colorectal Cancer Screening | 3 | 2.8 – 3 |
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 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 objective of this feasibility study is to determine navigation of the colon and tolerability of the Magnetic Flexible Endoscope (MFE) traveling in the human colon.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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