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

Last updated: December 19, 2024
Sponsor: Vanderbilt University Medical Center
Overall Status: Completed

Phase

N/A

Condition

Colon Cancer Screening

Treatment

Magnetic Flexible Endoscope (MFE)

Clinical Study ID

NCT05833789
MFE_222293
5R01EB018992-07
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 withuterus who are of childbearing potential will undergo either urine or bloodpregnancy testing

  5. Cancer positive subjects or any patients currently undergoing any treatment ortherapy to treat, cure, or mitigate cancer

  6. Symptoms consistent with coronavirus (COVID-19) --- pyrexia, new persistent cough oranosmia --- 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 (excludingaspirin) 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 Design

Total Participants: 5
Treatment Group(s): 1
Primary Treatment: Magnetic Flexible Endoscope (MFE)
Phase:
Study Start date:
October 12, 2023
Estimated Completion Date:
October 13, 2023

Study 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.

Connect with a study center

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

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