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

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ClinicalTrials.gov Identifier: NCT05833789
Recruitment Status : Completed
First Posted : April 27, 2023
Last Update Posted : April 12, 2024
Sponsor:
Collaborators:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Keith Obstein, Vanderbilt University Medical Center

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

Condition or disease Intervention/treatment
Colonoscopy 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 primary endpoint of the study is safety and tolerability of the MFE traveling in the human colon.
Study Design
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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE)
Actual Study Start Date : October 12, 2023
Actual Primary Completion Date : October 13, 2023
Actual Study Completion Date : October 13, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. MFE Safety [ Time Frame: 1 day ]
    Safety of the Magnetic Flexible Endoscope (MFE) traveling in the human colon.


Secondary Outcome Measures :
  1. MFE tolerability [ Time Frame: 1 day ]
    Patients tolerability of the MFE traveling in the human colon.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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.
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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05833789


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Keith L Obstein Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by Keith Obstein, Vanderbilt University Medical Center:
Informed Consent Form  [PDF] April 6, 2023

More Information
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Responsible Party: Keith Obstein, Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT05833789    
Other Study ID Numbers: MFE_222293
5R01EB018992-07 ( U.S. NIH Grant/Contract )
First Posted: April 27, 2023    Key Record Dates
Last Update Posted: April 12, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Keith Obstein, Vanderbilt University Medical Center:
Colonoscopy
Colon
Robotic
Magnetic
Endoscopy