Trial Outcomes & Findings for Use of a Distal Colonoscope Attachment to Increase Detection of Sessile Serrated Adenomas (NCT NCT03560037)
NCT ID: NCT03560037
Last Updated: 2025-09-22
Results Overview
Number of colonoscopies with at least one sessile serrated adenoma
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
427 participants
Primary outcome timeframe
Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion.
Results posted on
2025-09-22
Participant Flow
Participant milestones
| Measure |
Standard Colonoscopy
Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment.
|
Endocuff Vision Assisted Colonoscopy
Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment.
Endocuff Vision Assisted Colonoscopy: Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps.
|
|---|---|---|
|
Overall Study
STARTED
|
216
|
211
|
|
Overall Study
COMPLETED
|
215
|
210
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Standard Colonoscopy
Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment.
|
Endocuff Vision Assisted Colonoscopy
Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment.
Endocuff Vision Assisted Colonoscopy: Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Colonoscopy
n=216 Participants
Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment.
|
Endocuff Vision Assisted Colonoscopy
n=211 Participants
Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment.
Endocuff Vision Assisted Colonoscopy: Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps.
|
Total
n=427 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 7.2 • n=216 Participants
|
57.9 years
STANDARD_DEVIATION 7.7 • n=211 Participants
|
57.6 years
STANDARD_DEVIATION 7.5 • n=427 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=216 Participants
|
92 Participants
n=211 Participants
|
206 Participants
n=427 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=216 Participants
|
119 Participants
n=211 Participants
|
221 Participants
n=427 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index (BMI)
|
27.7 kg/m2
STANDARD_DEVIATION 4.9 • n=216 Participants
|
27.6 kg/m2
STANDARD_DEVIATION 4.6 • n=211 Participants
|
27.7 kg/m2
STANDARD_DEVIATION 4.8 • n=427 Participants
|
|
Alcohol consumption
Yes
|
153 Participants
n=216 Participants
|
145 Participants
n=211 Participants
|
298 Participants
n=427 Participants
|
|
Alcohol consumption
No
|
63 Participants
n=216 Participants
|
66 Participants
n=211 Participants
|
129 Participants
n=427 Participants
|
|
Smoking
Never
|
151 Participants
n=216 Participants
|
155 Participants
n=211 Participants
|
306 Participants
n=427 Participants
|
|
Smoking
Former
|
55 Participants
n=216 Participants
|
50 Participants
n=211 Participants
|
105 Participants
n=427 Participants
|
|
Smoking
Current
|
10 Participants
n=216 Participants
|
6 Participants
n=211 Participants
|
16 Participants
n=427 Participants
|
PRIMARY outcome
Timeframe: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion.Population: Participants with complete colonoscopy
Number of colonoscopies with at least one sessile serrated adenoma
Outcome measures
| Measure |
Standard Colonoscopy
n=215 Participants
Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment.
|
Endocuff Vision Assisted Colonoscopy
n=210 Participants
Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment.
Endocuff Vision Assisted Colonoscopy: Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps.
|
|---|---|---|
|
Sessile Serrated Adenomas
|
42 colonoscopies
|
59 colonoscopies
|
SECONDARY outcome
Timeframe: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion.Population: Participants with complete colonoscopy
Number of colonoscopies with at least one adenoma
Outcome measures
| Measure |
Standard Colonoscopy
n=215 Participants
Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment.
|
Endocuff Vision Assisted Colonoscopy
n=210 Participants
Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment.
Endocuff Vision Assisted Colonoscopy: Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps.
|
|---|---|---|
|
Adenoma Detection
|
159 colonoscopies
|
199 colonoscopies
|
SECONDARY outcome
Timeframe: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion.Number of colonoscopies with at least one sessile serrated adenoma or conventional adenoma
Outcome measures
| Measure |
Standard Colonoscopy
n=215 Participants
Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment.
|
Endocuff Vision Assisted Colonoscopy
n=210 Participants
Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment.
Endocuff Vision Assisted Colonoscopy: Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps.
|
|---|---|---|
|
Proximal Colon Adenomas
|
83 colonoscopies
|
99 colonoscopies
|
SECONDARY outcome
Timeframe: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion.Total adenomas detected in each treatment arm divided amongst the number of patients in each arm
Outcome measures
| Measure |
Standard Colonoscopy
n=215 Participants
Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment.
|
Endocuff Vision Assisted Colonoscopy
n=210 Participants
Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment.
Endocuff Vision Assisted Colonoscopy: Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps.
|
|---|---|---|
|
Adenomas Per Colonoscopy
|
0.96 adenomas per participant
Standard Deviation 1.33
|
1.24 adenomas per participant
Standard Deviation 1.67
|
SECONDARY outcome
Timeframe: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion.Total sessile serrated adenomas in each treatment arm divided amongst the number of patients in each arm.
Outcome measures
| Measure |
Standard Colonoscopy
n=215 Participants
Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment.
|
Endocuff Vision Assisted Colonoscopy
n=210 Participants
Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment.
Endocuff Vision Assisted Colonoscopy: Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps.
|
|---|---|---|
|
Sessile Serrated Adenomas Per Colonoscopy
|
0.27 Sessile Serrated Adenomas Per Participan
Standard Deviation 0.59
|
0.35 Sessile Serrated Adenomas Per Participan
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion.The total adenomas detected divided by the number of colonoscopies with at least one adenoma
Outcome measures
| Measure |
Standard Colonoscopy
n=215 Participants
Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment.
|
Endocuff Vision Assisted Colonoscopy
n=210 Participants
Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment.
Endocuff Vision Assisted Colonoscopy: Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps.
|
|---|---|---|
|
Adenomas Per Positive Colonoscopy
|
1.97 Adenomas Per Positive Colonoscopy
Standard Deviation 1.27
|
2.12 Adenomas Per Positive Colonoscopy
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion.The total sessile serrated adenomas detected divided by the number of colonoscopies with at least one sessile serrated adenoma
Outcome measures
| Measure |
Standard Colonoscopy
n=215 Participants
Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment.
|
Endocuff Vision Assisted Colonoscopy
n=210 Participants
Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment.
Endocuff Vision Assisted Colonoscopy: Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps.
|
|---|---|---|
|
Sessile Serrated Adenomas (SSA) Per Positive Colonoscopy
|
1.20 SSA Per Positive Colonoscopy
Standard Deviation 0.63
|
1.48 SSA Per Positive Colonoscopy
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Time point of assessment will be recorded at the time of colonoscopy. This data will be collected through study completion, analyzed and reported up to 6 months after study completion.The time it takes to withdraw the colonoscope from the cecum to the end of the examination.
Outcome measures
| Measure |
Standard Colonoscopy
n=215 Participants
Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment.
|
Endocuff Vision Assisted Colonoscopy
n=210 Participants
Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment.
Endocuff Vision Assisted Colonoscopy: Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps.
|
|---|---|---|
|
Colonoscope Withdrawal Time
|
14.74 minutes
Standard Deviation 0.28
|
15.01 minutes
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: Time point of assessment will be recorded at the time of colonoscopy. This data will be collected through study completion, analyzed and reported up to 6 months after study completion.Measurement of colon preparation based on the validated Boston Bowel Prep Score. Each colon segment (right, transverse, and left colons) will receive a score of 0 (worse) to 3 (best). The sum of each segment will be reported as a total score of 0 (worse) to 9 (best).
Outcome measures
| Measure |
Standard Colonoscopy
n=215 Participants
Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment.
|
Endocuff Vision Assisted Colonoscopy
n=210 Participants
Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment.
Endocuff Vision Assisted Colonoscopy: Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps.
|
|---|---|---|
|
Differences in Quality of Bowel Preparation
|
8.7 score on a scale (0 to 9)
Standard Deviation 0.8
|
8.7 score on a scale (0 to 9)
Standard Deviation 0.9
|
Adverse Events
Standard Colonoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Endocuff Vision Assisted 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
Christopher L. Bowlus, MD
University of California Davis
Phone: 916-734-8851
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place