Trial Outcomes & Findings for Standard Colonoscopy Versus Colonoscopy With Endocuff Vision (NCT NCT03361917)

Results Overview

Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

200 participants

Primary outcome timeframe

During the withdrawal portion of the colonoscopy procedure

Results posted on

2019-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	Control Arm (Standard Colonscopy) Standard colonoscopy with no device attachments	Endocuff Vision Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.
Overall Study STARTED	99	101
Overall Study COMPLETED	99	101
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Standard Colonoscopy Versus Colonoscopy With Endocuff Vision

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Endocuff Vision n=101 Participants Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.	Control Arm (Standard Colonscopy) n=99 Participants Standard colonoscopy with no device attachments	Total n=200 Participants Total of all reporting groups
Age, Continuous	62.7 Years STANDARD_DEVIATION 8.9 • n=5 Participants	61.7 Years STANDARD_DEVIATION 9.9 • n=7 Participants	62.2 Years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	57 Participants n=7 Participants	101 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	42 Participants n=7 Participants	99 Participants n=5 Participants
Race/Ethnicity, Customized White	87 Participants n=5 Participants	92 Participants n=7 Participants	179 Participants n=5 Participants
Race/Ethnicity, Customized Other	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	101 participants n=5 Participants	99 participants n=7 Participants	200 participants n=5 Participants
Gastroenterology fellows assisting in insertion	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Procedure Indication Screening	45 Participants n=5 Participants	52 Participants n=7 Participants	97 Participants n=5 Participants
Procedure Indication Surveillance	56 Participants n=5 Participants	47 Participants n=7 Participants	103 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the withdrawal portion of the colonoscopy procedure

Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch.

Outcome measures

Outcome measures
Measure	Endocuff Vision n=101 Participants Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.	Control Arm (Standard Colonscopy) n=99 Participants Standard colonoscopy with no device attachments
Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision)	6.49 Minutes Standard Error .10	8.42 Minutes Standard Error 0.12

SECONDARY outcome

Timeframe: During the insertion portion of the colonoscopy procedure

Insertion time is the time it takes from the colonoscope first being inserted to when the furthest section of the colon (which is called the cecum) is reached.

Outcome measures

Outcome measures
Measure	Endocuff Vision n=101 Participants Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.	Control Arm (Standard Colonscopy) n=99 Participants Standard colonoscopy with no device attachments
Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision)	4.05 Minutes Standard Error 0.16	4.42 Minutes Standard Error 0.19

SECONDARY outcome

Timeframe: During the colonoscopy procedure

Total procedure time is the time from the initial insertion through the complete withdrawal of the scope

Outcome measures

Outcome measures
Measure	Endocuff Vision n=101 Participants Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.	Control Arm (Standard Colonscopy) n=99 Participants Standard colonoscopy with no device attachments
Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision)	21.01 Minutes Standard Deviation 6.8	21.24 Minutes Standard Deviation 7.8

SECONDARY outcome

Timeframe: During the colonoscopy procedure

The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision.

Outcome measures

Outcome measures
Measure	Endocuff Vision n=101 Participants Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.	Control Arm (Standard Colonscopy) n=99 Participants Standard colonoscopy with no device attachments
Detection Rates Adenomas	61.4 Percentage of Participants Interval 51.6 to 70.3	52.5 Percentage of Participants Interval 42.8 to 62.1
Detection Rates Sessile serrated polyps	19.8 Percentage of Participants Interval 13.2 to 28.6	11.1 Percentage of Participants Interval 6.3 to 18.8

SECONDARY outcome

Timeframe: During the colonoscopy procedure

Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision.

Outcome measures

Outcome measures
Measure	Endocuff Vision n=101 Participants Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.	Control Arm (Standard Colonscopy) n=99 Participants Standard colonoscopy with no device attachments
Polyps Per Colonoscopy Adenomas	1.43 Polyps per colonoscopy Standard Error 1.79	1.07 Polyps per colonoscopy Standard Error 1.62
Polyps Per Colonoscopy Sessile serrated polyps	0.27 Polyps per colonoscopy Standard Error 0.63	0.21 Polyps per colonoscopy Standard Error 0.70

SECONDARY outcome

Timeframe: During the withdrawal portion of the colonoscopy procedure after cleaning of the colon

Boston Bowel Preparation Score for patients receiving standard colonoscopy compared to colonoscopy with endocuff vision. The total score for the Boston Bowel Preparation Scale ranges from 0 to 9, with higher score indicating a better bowel preparation quality. The quality of the bowel preparation is assessed by the attending gastroenterologist.

Outcome measures

Outcome measures
Measure	Endocuff Vision n=101 Participants Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.	Control Arm (Standard Colonscopy) n=99 Participants Standard colonoscopy with no device attachments
Boston Bowel Preparation Score	9 Scores on a scale Interval 3.0 to 9.0	9 Scores on a scale Interval 3.0 to 9.0

Adverse Events

Control Arm (Standard Colonscopy)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Endocuff Vision

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

Rachel Lahr

Indiana University

Phone: 3179480724

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place