Trial Outcomes & Findings for Visualization of the Colon Through Use of the Magnetic Flexible Endoscope (MFE) (NCT NCT05833789)

Results Overview

Number of participants with successful MFE navigation to the cecum from the rectum of the colon in less than 40 minutes

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

Day 1

Results posted on

2024-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Colonoscopy for Colorectal Cancer Screening n=5 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Number of participants with successful MFE navigation to the cecum from the rectum of the colon in less than 40 minutes

Outcome measures

Outcome measures
Measure	Colonoscopy for Colorectal Cancer Screening n=5 Participants 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.
MFE Navigation to the Cecum From the Rectum in Less Than 40 Minutes	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Colonoscopy for Colorectal Cancer Screening n=5 Participants 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.
MFE Tolerability by Post-procedure Interview	0 events

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Colonoscopy for Colorectal Cancer Screening n=5 Participants 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.
Endoscopist Experience by NASA Task Load Index (TLX) Mental	31 score on a scale Interval 28.0 to 33.0
Endoscopist Experience by NASA Task Load Index (TLX) Physical	44 score on a scale Interval 29.0 to 47.0
Endoscopist Experience by NASA Task Load Index (TLX) Temporal	28 score on a scale Interval 25.0 to 31.0
Endoscopist Experience by NASA Task Load Index (TLX) Performance	47 score on a scale Interval 46.0 to 47.0
Endoscopist Experience by NASA Task Load Index (TLX) Effort	36 score on a scale Interval 29.0 to 45.0
Endoscopist Experience by NASA Task Load Index (TLX) Frustration	40 score on a scale Interval 32.0 to 45.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Colonoscopy for Colorectal Cancer Screening n=5 Participants 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.
Colon Mucosal Visibility	3 score on a scale Interval 2.8 to 3.0

Adverse Events

Colonoscopy for Colorectal Cancer Screening

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael McGill

Vanderbilt University Medical Center

Phone: 615-322-0128

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place