Clinical trial NCT05833789: Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE)
Official title: Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Keywords: Colonoscopy
Colon
Robotic
Magnetic
Endoscopy
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
name: National Institutes of Health (NIH)
First posted: 2023-04-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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

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

Primary outcomes:
measure: MFE Navigation to the Cecum From the Rectum in Less Than 40 Minutes
timeFrame: Day 1
Secondary outcomes:
measure: MFE Tolerability by Post-procedure Interview
timeFrame: Day 1
measure: Endoscopist Experience by NASA Task Load Index (TLX)
timeFrame: Day 1
measure: Colon Mucosal Visibility
timeFrame: Day 1
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Keith L Obstein
role: PRINCIPAL_INVESTIGATOR
References: