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

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Device: Magnetic Flexible Endoscope (MFE)

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

The study population for this study are patients who are already scheduled to undergo their age appropriate standard-of-care colonoscopy for colorectal cancer screening (ICD-10: z12.11). Colonoscopy is recommended as the gold standard for colorectal cancer screening for men and women beginning at age 45-years old and is an effective tool to prevent colon cancer as the colon lining (mucosa) can be visualized for pre-cancers lesions (polyps) and for cancer.

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colonoscopy for colorectal cancer screening; 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).	Device: Magnetic Flexible Endoscope (MFE); 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MFE Tolerability by Post-procedure Interview	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.	Day 1
Endoscopist Experience by NASA Task Load Index (TLX)	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.	Day 1
Colon Mucosal Visibility	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.	Day 1

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Institutes of Health (NIH); National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Investigators: Principal Investigator: Keith L Obstein, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Actual): October 13, 2023
• Study Completion (Actual): October 13, 2023

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Endoscopy; Colonoscopy; Robotic; Colon; Magnetic
• Other Study ID Numbers: MFE_222293; 5R01EB018992-07 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes