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

Study Overview
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Brief Summary
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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 if the Magnetic Flexible Endoscope (MFE) can travel from the rectum to the cecum in the human colon.

Detailed Description
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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 primary endpoint of the study is successful navigation of the MFE from the rectum to the patient's cecum.

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

Conditions
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Colonoscopy

Intervention / Treatment
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* Device: Magnetic Flexible Endoscope (MFE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18 to 70 years of age. Able to provide written informed consent. ASA class < 3 No significant medical problems Abdominal circumference < 96 cm 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) 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 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) PCR swab result Previous failed colonoscopy Colonic resection Severe diverticulosis Known or suspected colonic stricture Previous radiation therapy to the abdomen or pelvis Any active inflammatory bowel condition (e.g. active IBD or diverticulitis) Known or suspected bowel obstruction Presence of ascites Participants taking anticoagulant medications or antiplatelet therapy (excluding aspirin) within the last 7 days Known coagulation disorder (INR ≥ 1.5 or platelets < 150 x 10^9) Known to have phenylketonuria or G6PD deficiency Abdominal surgery within the last 6 months Drug or alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colonoscopy for colorectal cancer screening<br>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) to determine if the MFE can travel from the rectum to the cecum. | Device: Magnetic Flexible Endoscope (MFE)<br>* After colonoscopy has been completed with the legacy colonoscope, the MFE will be introduced into the colon and traverse from the rectum to the cecum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cecum intubation rate | Successful intubation of the cecum with the Magnetic Flexible Endoscope (MFE). | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Colon, Robotic, Magnetic, Endoscopy