Colonoscopy
Conditions
Keywords
Colonoscopy, Colon, Robotic, Magnetic, Endoscopy
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.
Interventions
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.
Sponsors
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
National Institutes of Health (NIH)
Vanderbilt University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MFE Navigation to the Cecum From the Rectum in Less Than 40 Minutes | Day 1 | Number of participants with successful MFE navigation to the cecum from the rectum of the colon in less than 40 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MFE Tolerability by Post-procedure Interview | Day 1 | Number of reported non-tolerability events, including events associated with the product's administration affecting the ability or desire of the patient to adhere to the intensity of therapy. Tolerability was assessed through qualitative interview post procedure. |
| Endoscopist Experience by NASA Task Load Index (TLX) | Day 1 | The NASA Task Load Index (TLX) is a validated assessment instrument (Ames Research Center, Moffett Field, CA, USA) to assess perceived workload based on a multidimensional construct of six sub-scales: mental demand, physical demand, temporal demand, performance, effort, and frustration level. The sub-scales range from 0 (very low) to 100 (very high); the exception is the sub-scale of performance, where 0 is perfect and 100 is failure. |
| Colon Mucosal Visibility | Day 1 | Colon mucosal visibility scale is an operator assessed cumulative score utilizing the colon visualization index which has a score range of 0-4, where 0 is poor and 4 is excellent. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
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. | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Colonoscopy for Colorectal Cancer Screening |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
MFE Navigation to the Cecum From the Rectum in Less Than 40 Minutes
Number of participants with successful MFE navigation to the cecum from the rectum of the colon in less than 40 minutes
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Colonoscopy for Colorectal Cancer Screening | MFE Navigation to the Cecum From the Rectum in Less Than 40 Minutes | 0 Participants |
Secondary
Colon Mucosal Visibility
Colon mucosal visibility scale is an operator assessed cumulative score utilizing the colon visualization index which has a score range of 0-4, where 0 is poor and 4 is excellent.
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Colonoscopy for Colorectal Cancer Screening | Colon Mucosal Visibility | 3 score on a scale |
Secondary
Endoscopist Experience by NASA Task Load Index (TLX)
The NASA Task Load Index (TLX) is a validated assessment instrument (Ames Research Center, Moffett Field, CA, USA) to assess perceived workload based on a multidimensional construct of six sub-scales: mental demand, physical demand, temporal demand, performance, effort, and frustration level. The sub-scales range from 0 (very low) to 100 (very high); the exception is the sub-scale of performance, where 0 is perfect and 100 is failure.
Time frame: Day 1
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Colonoscopy for Colorectal Cancer Screening | Endoscopist Experience by NASA Task Load Index (TLX) | Mental | 31 score on a scale |
| Colonoscopy for Colorectal Cancer Screening | Endoscopist Experience by NASA Task Load Index (TLX) | Physical | 44 score on a scale |
| Colonoscopy for Colorectal Cancer Screening | Endoscopist Experience by NASA Task Load Index (TLX) | Temporal | 28 score on a scale |
| Colonoscopy for Colorectal Cancer Screening | Endoscopist Experience by NASA Task Load Index (TLX) | Performance | 47 score on a scale |
| Colonoscopy for Colorectal Cancer Screening | Endoscopist Experience by NASA Task Load Index (TLX) | Effort | 36 score on a scale |
| Colonoscopy for Colorectal Cancer Screening | Endoscopist Experience by NASA Task Load Index (TLX) | Frustration | 40 score on a scale |
Secondary
MFE Tolerability by Post-procedure Interview
Number of reported non-tolerability events, including events associated with the product's administration affecting the ability or desire of the patient to adhere to the intensity of therapy. Tolerability was assessed through qualitative interview post procedure.
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Colonoscopy for Colorectal Cancer Screening | MFE Tolerability by Post-procedure Interview | 0 events |