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

Not Applicable

Completed

Conditions: Colonoscopy

Interventions: Device: Magnetic Flexible Endoscope (MFE)

Registration Number: NCT05833789

Lead Sponsor: Vanderbilt University Medical Center

Brief 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 navigation of the colon and tolerability of the Magnetic Flexible Endoscope (MFE) traveling in the human colon.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 5

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Colonoscopy for colorectal cancer screening	Magnetic Flexible Endoscope (MFE)	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).

Primary Outcome Measures

Name	Time	Method
MFE Navigation to the Cecum From the Rectum in Less Than 40 Minutes	Day 1	Number of participants with successful MFE navigation to the cecum from the rectum of the colon in less than 40 minutes

Secondary Outcome Measures

Name	Time	Method
MFE Tolerability by Post-procedure Interview	Day 1	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.
Endoscopist Experience by NASA Task Load Index (TLX)	Day 1	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.
Colon Mucosal Visibility	Day 1	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.