Colon Cancer Clinical Trial

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

Summary

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.

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

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Eligibility Criteria

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

Study is for people with:

Colon Cancer

Estimated Enrollment:

5

Study ID:

NCT05833789

Recruitment Status:

Enrolling by invitation

Sponsor:

Vanderbilt University Medical Center

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There is 1 Location for this study

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Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States

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Study is for people with:

Colon Cancer

Estimated Enrollment:

5

Study ID:

NCT05833789

Recruitment Status:

Enrolling by invitation

Sponsor:


Vanderbilt University Medical Center

How clear is this clinincal trial information?

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