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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05833789
• Other study ID #: MFE_222293
• Secondary ID: 5R01EB018992-07
• Status: Completed
• Start date: October 12, 2023
• Est. completion date: October 13, 2023

Study information

• Verified date: April 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 safety and tolerability of the Magnetic Flexible Endoscope (MFE) traveling in the human colon.

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 safety and tolerability of the MFE traveling in the human colon.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 13, 2023
• Est. primary completion date: October 13, 2023
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MFE Safety	Safety of the Magnetic Flexible Endoscope (MFE) traveling in the human colon.	1 day
Secondary	MFE tolerability	Patients tolerability of the MFE traveling in the human colon.	1 day