Trial Outcomes & Findings for EndoRings Colonoscopy vs Standard Colonoscopy (NCT NCT03418662)

Results Overview

Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

592 participants

Primary outcome timeframe

During colonoscopy procedure

Results posted on

2019-09-20

Participant Flow

592 patients were enrolled in the study, but 17 were excluded before randomization for not meeting inclusion criteria. 569 patients were randomized.

Participant milestones

Participant milestones
Measure	EndoRings Colonoscopy Colonoscopy with EndoRings device attached to the distal end of the scope. EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure.	Control Arm (Standard Colonoscopy) Standard colonoscopy with no device attachment.
Overall Study STARTED	287	282
Overall Study COMPLETED	284	278
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EndoRings Colonoscopy vs Standard Colonoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EndoRings Colonoscopy n=284 Participants Colonoscopy with EndoRings device attached to the distal end of the scope. EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure.	Control Arm (Standard Colonoscopy) n=278 Participants Standard colonoscopy with no device attachment.	Total n=562 Participants Total of all reporting groups
Age, Continuous	61.9 Years STANDARD_DEVIATION 8.1 • n=113 Participants	61.0 Years STANDARD_DEVIATION 7.9 • n=163 Participants	61.5 Years STANDARD_DEVIATION 9.1 • n=160 Participants
Sex: Female, Male Female	131 Participants n=113 Participants	142 Participants n=163 Participants	273 Participants n=160 Participants
Sex: Female, Male Male	153 Participants n=113 Participants	136 Participants n=163 Participants	289 Participants n=160 Participants
Race/Ethnicity, Customized White	233 Participants n=113 Participants	222 Participants n=163 Participants	455 Participants n=160 Participants
Race/Ethnicity, Customized Other	51 Participants n=113 Participants	56 Participants n=163 Participants	107 Participants n=160 Participants
Region of Enrollment United States	284 participants n=113 Participants	278 participants n=163 Participants	562 participants n=160 Participants
Indication for Colonoscopy Patients who had a screening colonoscopy	143 Participants n=113 Participants	162 Participants n=163 Participants	305 Participants n=160 Participants
Indication for Colonoscopy Patients who had a surveillance colonoscopy	141 Participants n=113 Participants	116 Participants n=163 Participants	257 Participants n=160 Participants

PRIMARY outcome

Timeframe: During colonoscopy procedure

Number of participants with at least one adenoma detected, during Standard Colonoscopy compared with colonoscopy with EndoRings.

Outcome measures

Outcome measures
Measure	EndoRings Colonoscopy n=284 Participants Colonoscopy with EndoRings device attached to the distal end of the scope. EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure.	Control Arm (Standard Colonoscopy) n=278 Participants Standard colonoscopy with no device attachment.
Adenoma Detection Rates	143 Participants	124 Participants

PRIMARY outcome

Timeframe: During colonoscopy procedure

Comparison of the number of adenomas detected per colonoscopy between standard colonoscopy and EndoRings colonoscopy.

Outcome measures

Outcome measures
Measure	EndoRings Colonoscopy n=284 Participants Colonoscopy with EndoRings device attached to the distal end of the scope. EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure.	Control Arm (Standard Colonoscopy) n=278 Participants Standard colonoscopy with no device attachment.
Number of Adenomas Per Colonoscopy	1.46 adenomas per colonoscopy Standard Deviation 2.69	1.06 adenomas per colonoscopy Standard Deviation 1.83

SECONDARY outcome

Timeframe: During colonoscopy procedure

Number of subjects with at least one polyp detected with Standard Colonoscopy compared to colonoscopy with EndoRings.

Outcome measures

Outcome measures
Measure	EndoRings Colonoscopy n=284 Participants Colonoscopy with EndoRings device attached to the distal end of the scope. EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure.	Control Arm (Standard Colonoscopy) n=278 Participants Standard colonoscopy with no device attachment.
Polyp Detection Rate	199 Participants	188 Participants

SECONDARY outcome

Timeframe: During colonoscopy procedure

Comparison of the number of polyps detected per colonoscopy between EndoRings colonoscopy and Standard colonoscopy.

Outcome measures

Outcome measures
Measure	EndoRings Colonoscopy n=284 Participants Colonoscopy with EndoRings device attached to the distal end of the scope. EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure.	Control Arm (Standard Colonoscopy) n=278 Participants Standard colonoscopy with no device attachment.
Number of Detections Per Colonoscopy	2.29 polyps per colonoscopy Standard Deviation 3.09	1.82 polyps per colonoscopy Standard Deviation 2.19

SECONDARY outcome

Timeframe: During colonoscopy procedure

Comparison of the total number of polyps detected and the total number of adenomas detected between EndoRings colonoscopy and Standard colonoscopy.

Outcome measures

Outcome measures
Measure	EndoRings Colonoscopy n=284 Participants Colonoscopy with EndoRings device attached to the distal end of the scope. EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure.	Control Arm (Standard Colonoscopy) n=278 Participants Standard colonoscopy with no device attachment.
Total Number of Detections Polyps	415 Detections	295 Detections
Total Number of Detections Adenomas	650 Detections	506 Detections

SECONDARY outcome

Timeframe: During colonoscopy procedure

Comparison of cecal intubation rate (the number of procedures where the colonoscope was able to be inserted all the way to the cecum) between standard colonoscopy and EndoRings colonoscopy.

Outcome measures

Outcome measures
Measure	EndoRings Colonoscopy n=284 Participants Colonoscopy with EndoRings device attached to the distal end of the scope. EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure.	Control Arm (Standard Colonoscopy) n=278 Participants Standard colonoscopy with no device attachment.
Cecal Intubation Rate	281 Participants	277 Participants

SECONDARY outcome

Timeframe: During colonoscopy procedure

Comparison of the time required to reach the cecum, withdrawal time, and total procedure time. Insertion time: time required to reach the cecum Withdrawal time: time calculated from when withdrawing is started in the cecum till the colonoscope is removed. This includes time spent washing, inspecting the colon and removing polyps. Total procedure time: This is the sum of insertion and withdrawal times along with any time spent washing or removing polyps while in the cecum (before starting withdrawal).

Outcome measures

Outcome measures
Measure	EndoRings Colonoscopy n=284 Participants Colonoscopy with EndoRings device attached to the distal end of the scope. EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure.	Control Arm (Standard Colonoscopy) n=278 Participants Standard colonoscopy with no device attachment.
Time Comparison for Each Method Total Withdrawal Time	11.8 Minutes Standard Deviation 6.1	12.8 Minutes Standard Deviation 5.9
Time Comparison for Each Method Total Procedure Time	19.4 Minutes Standard Deviation 8.2	19.5 Minutes Standard Deviation 7.9
Time Comparison for Each Method Insertion Time	6.3 Minutes Standard Deviation 4.4	5.5 Minutes Standard Deviation 3.4

SECONDARY outcome

Timeframe: After colonoscopy was completed while patient was in recovery area of endoscopy unit

Comparison of patient comfort between Standard colonoscopy and EndoRings colonoscopy on a scale of 0 to 10 with 0 being no pain (best outcome) and 10 being worst imaginable pain (worst outcome).

Outcome measures

Outcome measures
Measure	EndoRings Colonoscopy n=284 Participants Colonoscopy with EndoRings device attached to the distal end of the scope. EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure.	Control Arm (Standard Colonoscopy) n=278 Participants Standard colonoscopy with no device attachment.
Patient Comfort Score	0.47 units on a scale Standard Deviation 1.1	0.36 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: During colonoscopy procedure

Population: This outcome measure is not applicable for patients randomized to the standard arm because there is no device attached in the standard arm of the study. For this reason, 0 patients are reported for the standard arm for this specific outcome measure.

Occurrences of slippage of EndoRings or of device being removed on insertion.

Outcome measures

Outcome measures
Measure	EndoRings Colonoscopy n=284 Participants Colonoscopy with EndoRings device attached to the distal end of the scope. EndoRings device: Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure.	Control Arm (Standard Colonoscopy) Standard colonoscopy with no device attachment.
Problems Encountered With Equipment Procedures with slippage of device	17 Participants	—
Problems Encountered With Equipment Procedures where device was removed	25 Participants	—

Adverse Events

EndoRings Colonoscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm (Standard Colonoscopy)

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: 317-948-0724

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place