Trial Outcomes & Findings for Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy (NCT NCT03560128)
NCT ID: NCT03560128
Last Updated: 2019-10-08
Results Overview
Comparison of the number of adenomas detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.
COMPLETED
NA
634 participants
During colonoscopy procedure
2019-10-08
Participant Flow
Participant milestones
| Measure |
AmplifEYE Arm
Colonoscopy with AmplifEYE device attached to the distal end of the scope.
AmplifEYE device: Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.
|
Endocuff Vision Arm
Colonoscopy with Endocuff Vision device attached to the distal end of the scope.
Endocuff Vision device: Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
306
|
306
|
|
Overall Study
COMPLETED
|
294
|
298
|
|
Overall Study
NOT COMPLETED
|
12
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Endocuff Vision Colonoscopy vs. AmplifEYE Colonoscopy
Baseline characteristics by cohort
| Measure |
AmplifEYE Arm
n=294 Participants
Colonoscopy with AmplifEYE device attached to the distal end of the scope.
AmplifEYE device: Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.
|
Endocuff Vision Arm
n=298 Participants
Colonoscopy with Endocuff Vision device attached to the distal end of the scope.
Endocuff Vision device: Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.
|
Total
n=592 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 10 • n=99 Participants
|
63.2 years
STANDARD_DEVIATION 9.7 • n=107 Participants
|
62.7 years
STANDARD_DEVIATION 9.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
155 Participants
n=99 Participants
|
170 Participants
n=107 Participants
|
325 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=99 Participants
|
128 Participants
n=107 Participants
|
267 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
264 Participants
n=99 Participants
|
268 Participants
n=107 Participants
|
532 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
294 participants
n=99 Participants
|
298 participants
n=107 Participants
|
592 participants
n=206 Participants
|
|
Indication for Procedure
Screening
|
100 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
213 Participants
n=206 Participants
|
|
Indication for Procedure
Diagnostic
|
18 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
|
Indication for Procedure
Surveillance
|
171 Participants
n=99 Participants
|
160 Participants
n=107 Participants
|
331 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: During colonoscopy procedureComparison of the number of adenomas detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.
Outcome measures
| Measure |
AmplifEYE Arm
n=294 Participants
Colonoscopy with AmplifEYE device attached to the distal end of the scope.
AmplifEYE device: Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.
|
Endocuff Vision Arm
n=298 Participants
Colonoscopy with Endocuff Vision device attached to the distal end of the scope.
Endocuff Vision device: Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.
|
|---|---|---|
|
Number of Adenomas Detected Per Colonoscopy (APC).
|
1.63 adenomas
Standard Deviation 2.8
|
1.51 adenomas
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: During colonoscopy procedureComparison of the number of participants with at least one adenoma detected (ADR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. Comparison of the number of participants with at least one polyp detected (PDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.
Outcome measures
| Measure |
AmplifEYE Arm
n=294 Participants
Colonoscopy with AmplifEYE device attached to the distal end of the scope.
AmplifEYE device: Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.
|
Endocuff Vision Arm
n=298 Participants
Colonoscopy with Endocuff Vision device attached to the distal end of the scope.
Endocuff Vision device: Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.
|
|---|---|---|
|
Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR))
at least 1 detected polyp
|
229 Participants
|
231 Participants
|
|
Detection Rates (Adenoma Detection Rate (ADR) and Polyp Detection Rate (PDR))
at least 1 detected adenoma
|
164 Participants
|
159 Participants
|
SECONDARY outcome
Timeframe: During Colonoscopy procedureComparison of amount of mucosal trauma (such as scratches), perforation (making a hole in the colon wall), or gastrointestinal bleeding between patients that have AmplifEYE colonoscopy compared to patients that have Endocuff Vision colonoscopy.
Outcome measures
| Measure |
AmplifEYE Arm
n=294 Participants
Colonoscopy with AmplifEYE device attached to the distal end of the scope.
AmplifEYE device: Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.
|
Endocuff Vision Arm
n=298 Participants
Colonoscopy with Endocuff Vision device attached to the distal end of the scope.
Endocuff Vision device: Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.
|
|---|---|---|
|
Complications Encountered During Procedure
Mucosal Trauma
|
30 Participants
|
24 Participants
|
|
Complications Encountered During Procedure
GI Bleeding
|
0 Participants
|
0 Participants
|
|
Complications Encountered During Procedure
Perforation
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: during insertion portion of colonoscopyComparison of the number of times the device had to be removed to pass the sigmoid colon between colonoscopies with the AmplifEYE device and colonoscopies with the Endocuff Vision device.
Outcome measures
| Measure |
AmplifEYE Arm
n=294 Participants
Colonoscopy with AmplifEYE device attached to the distal end of the scope.
AmplifEYE device: Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.
|
Endocuff Vision Arm
n=298 Participants
Colonoscopy with Endocuff Vision device attached to the distal end of the scope.
Endocuff Vision device: Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.
|
|---|---|---|
|
Passage of Device Through Sigmoid Colon
|
17 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: During colonoscopy procedureComparison of the number of polyps detected per colonoscopy between the Endocuff Vision Colonoscopy and the AmplifEYE colonoscopy.
Outcome measures
| Measure |
AmplifEYE Arm
n=294 Participants
Colonoscopy with AmplifEYE device attached to the distal end of the scope.
AmplifEYE device: Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.
|
Endocuff Vision Arm
n=298 Participants
Colonoscopy with Endocuff Vision device attached to the distal end of the scope.
Endocuff Vision device: Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.
|
|---|---|---|
|
Polyps Per Colonoscopy (PPC)
|
2.71 Polyps
Standard Deviation 3.4
|
2.55 Polyps
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: During colonoscopy procedureComparison of the insertion time, overall withdrawal time, inspection time, and total procedure time between the AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. Insertion time: time it takes from the colonoscope first being inserted to when the cecum is reached Withdrawal time: time calculated from when withdrawing is started in the cecum until the colonoscope is removed. This includes time spent washing, suctioning, inspecting the colon, and removing polyps. Inspection time: time spent actually examining the colon and does not include time spent for washing the colon, suctioning, and removing polyps. Total procedure time: time from the initial insertion of the colonoscope through the complete withdrawal of the colonoscope.
Outcome measures
| Measure |
AmplifEYE Arm
n=294 Participants
Colonoscopy with AmplifEYE device attached to the distal end of the scope.
AmplifEYE device: Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.
|
Endocuff Vision Arm
n=298 Participants
Colonoscopy with Endocuff Vision device attached to the distal end of the scope.
Endocuff Vision device: Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.
|
|---|---|---|
|
Time Comparison for Each Method
Insertion Time
|
5.6 Minutes
Standard Deviation 3.7
|
5.7 Minutes
Standard Deviation 4.1
|
|
Time Comparison for Each Method
Overall Withdrawal Time
|
14.6 Minutes
Standard Deviation 6.2
|
14.9 Minutes
Standard Deviation 6.3
|
|
Time Comparison for Each Method
Inspection Time
|
6.8 Minutes
Standard Deviation 2.3
|
6.9 Minutes
Standard Deviation 1.6
|
|
Time Comparison for Each Method
Total Procedure Time
|
21.1 Minutes
Standard Deviation 7.8
|
21.5 Minutes
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: During Colonoscopy procedureComparison of the number of procedures where the colonoscope was able to reach the cecum between AmplifEYE colonoscopy and Endocuff Vision colonoscopy.
Outcome measures
| Measure |
AmplifEYE Arm
n=294 Participants
Colonoscopy with AmplifEYE device attached to the distal end of the scope.
AmplifEYE device: Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.
|
Endocuff Vision Arm
n=298 Participants
Colonoscopy with Endocuff Vision device attached to the distal end of the scope.
Endocuff Vision device: Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.
|
|---|---|---|
|
Cecal Intubation Rate
|
294 Participants
|
297 Participants
|
SECONDARY outcome
Timeframe: During colonoscopy procedureComparison of the number of participants with at least one Sessile Serrated Polyp detected (SSPDR) between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy. Comparison of the number of participants with at least one flat polyp detected between AmplifEYE colonoscopy and the Endocuff Vision colonoscopy.
Outcome measures
| Measure |
AmplifEYE Arm
n=294 Participants
Colonoscopy with AmplifEYE device attached to the distal end of the scope.
AmplifEYE device: Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.
|
Endocuff Vision Arm
n=298 Participants
Colonoscopy with Endocuff Vision device attached to the distal end of the scope.
Endocuff Vision device: Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.
|
|---|---|---|
|
Detection of Serrated Lesions
at least one sessile serrated polyp detected
|
40 Participants
|
46 Participants
|
|
Detection of Serrated Lesions
at least one flat polyp detected
|
122 Participants
|
130 Participants
|
Adverse Events
AmplifEYE Arm
Endocuff Vision Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place