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

NCT ID: NCT05833789

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-12
• Study Completion Date: 2023-10-13

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.

Conditions

Colonoscopy

Keywords

Colonoscopy; Colon; Robotic; Magnetic; Endoscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Magnetic Flexible Endoscope (MFE)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Keith Obstein

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keith L Obstein

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

Obstein KL, Landewee CA, Martin J, Calo S, Norton J, Wai Kow J, Scaglioni B, Valdastri P. The Magnetic Flexible Endoscope: Phase 1 First-in-Human Clinical Trial. Am J Gastroenterol. 2025 Jun 10:10.14309/ajg.0000000000003584. doi: 10.14309/ajg.0000000000003584. Online ahead of print.

Reference Type: DERIVED

PMID: 40493042 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R01EB018992-07

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MFE_222293

Identifier Type: -

Identifier Source: org_study_id