Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE)

Vanderbilt University Medical Center

Status: Completed

Conditions: Colonoscopy

Treatments: Device: Magnetic Flexible Endoscope (MFE)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05833789

MFE_222293

5R01EB018992-07 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

The clinical practice at Vanderbilt University Medical Center (VUMC) is to perform the screening colonoscopic exam while the patient is sedated (Monitored Anesthesia Care administered by the VUMC out-of-OR Anesthesia team) with a legacy colonoscope (Olympus CF/PCF-H190L; Olympus America, Center Valley, PA, USA) to evaluate the patient's colon (via the rectum passed trans-anally with the intent of reaching the cecum). After the screening examination with the legacy colonoscope has been completed and the legacy colonoscope is removed from the patient, the sedation for the patient is stopped as per the standard of care. The patient will be monitored as per VUMC standard of care post-sedation monitoring protocol in the procedure room (post-sedation recovery phase). While the patient is in the post-sedation recovery phase in the procedure room, the MFE will be inserted trans-anally into the rectum and traverse the colon with the intent on reaching the cecum. No additional sedation is administered. After the cecum is visualized, the MFE will be removed from the patient. The patient will continue to be monitored as per VUMC standard of care post-procedure monitoring protocol in the procedure room. Once VUMC standard of care discharge parameters have been met, the patient will be discharged from the procedure area/VUMC as per standard of care. The investigators plan to enroll 5 healthy patients who are already scheduled to undergo their standard of care colonoscopic exam for age-appropriate colorectal cancer screening. The endpoints of the study are navigation of the colon, mucosal visibility, tolerability of the MFE traveling in the human colon, and endoscopist assessment.

Enrollment: 5 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, 18 to 70 years of age.
2. Able to provide written informed consent.
3. ASA class < 3
4. No significant medical problems
5. Abdominal circumference < 96 cm

Exclusion criteria

1. Patients who do not meet inclusion criteria
2. Patients who are unable or unwilling to provide informed consent
3. Magnetic implants and wearable devices (such as insulin pumps)
4. Patients who are pregnant. As part of routine pre-operative care, all patients with uterus who are of childbearing potential will undergo either urine or blood pregnancy testing
5. Cancer positive subjects or any patients currently undergoing any treatment or therapy to treat, cure, or mitigate cancer
6. Symptoms consistent with coronavirus (COVID-19) --- pyrexia, new persistent cough or anosmia --- or a positive coronavirus (COVID-19) PCR swab result
7. Previous failed colonoscopy
8. Colonic resection
9. Severe diverticulosis
10. Known or suspected colonic stricture
11. Previous radiation therapy to the abdomen or pelvis
12. Any active inflammatory bowel condition (e.g. active IBD or diverticulitis)
13. Known or suspected bowel obstruction
14. Presence of ascites
15. Participants taking anticoagulant medications or antiplatelet therapy (excluding aspirin) within the last 7 days
16. Known coagulation disorder (INR ≥ 1.5 or platelets < 150 x 10^9)
17. Known to have phenylketonuria or G6PD deficiency
18. Abdominal surgery within the last 6 months
19. Drug or alcohol abuse

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Colonoscopy for colorectal cancer screening

Experimental group

Description:

All patients in this group will have their colonoscopy for colorectal cancer screening completed with a legacy colonoscope followed by colonoscopy with the Magnetic Flexible Endoscope (MFE).

Treatment:

Device: Magnetic Flexible Endoscope (MFE)