Trial Outcomes & Findings for Does Cap Assisted Colonoscopy Improve Detection of Adenomatous Polyps? (CAP Trial) (NCT NCT01935180)
NCT ID: NCT01935180
Last Updated: 2018-09-25
Results Overview
Mean number of adenomas per patient in each group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1148 participants
Primary outcome timeframe
duration of colonoscopy
Results posted on
2018-09-25
Participant Flow
Participant milestones
| Measure |
Standard Colonoscopy
Standard colonoscopy without an attachment cap
|
Cap Assisted Colonoscopy
A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
Colonoscopy Cap: 4mm transparent cap (Olympus) mounted to the tip of a colonoscope.
|
|---|---|---|
|
Overall Study
STARTED
|
573
|
575
|
|
Overall Study
COMPLETED
|
552
|
561
|
|
Overall Study
NOT COMPLETED
|
21
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Colonoscopy
n=552 Participants
Standard colonoscopy without an attachment cap
|
Cap Assisted Colonoscopy
n=561 Participants
A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
Colonoscopy Cap: 4mm transparent cap (Olympus) mounted to the tip of a colonoscope.
|
Total
n=1113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 8.4 • n=552 Participants
|
62.5 years
STANDARD_DEVIATION 8.3 • n=561 Participants
|
61.8 years
STANDARD_DEVIATION 8.3 • n=1113 Participants
|
|
Sex: Female, Male
Female
|
209 Participants
n=552 Participants
|
195 Participants
n=561 Participants
|
404 Participants
n=1113 Participants
|
|
Sex: Female, Male
Male
|
343 Participants
n=552 Participants
|
366 Participants
n=561 Participants
|
709 Participants
n=1113 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
552 participants
n=552 Participants
|
561 participants
n=561 Participants
|
1113 participants
n=1113 Participants
|
|
Indication
Colonoscopy performed for cancer screening
|
291 Participants
n=552 Participants
|
292 Participants
n=561 Participants
|
583 Participants
n=1113 Participants
|
|
Indication
Colonoscopy performed for polyp surveillance
|
168 Participants
n=552 Participants
|
171 Participants
n=561 Participants
|
339 Participants
n=1113 Participants
|
|
Indication
Colonoscopy performed for symptoms (diagnostic)
|
93 Participants
n=552 Participants
|
98 Participants
n=561 Participants
|
191 Participants
n=1113 Participants
|
PRIMARY outcome
Timeframe: duration of colonoscopyMean number of adenomas per patient in each group.
Outcome measures
| Measure |
Standard Colonoscopy
n=552 Participants
Colonoscopy without a cap.
|
Cap Assisted Colonoscopy
n=561 Participants
A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
|
|---|---|---|
|
Mean Number of Adenomas
|
0.82 adenoma per patient
Standard Deviation 1.5
|
0.89 adenoma per patient
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: duration of colonoscopy• Adenoma detection rate (ADR), % of patients with at least 1 adenoma
Outcome measures
| Measure |
Standard Colonoscopy
n=552 Participants
Colonoscopy without a cap.
|
Cap Assisted Colonoscopy
n=561 Participants
A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
|
|---|---|---|
|
Adenoma Detection Rate
|
219 Participants
|
235 Participants
|
SECONDARY outcome
Timeframe: duration of colonoscopyProportion of patients with advanced adenomas
Outcome measures
| Measure |
Standard Colonoscopy
n=552 Participants
Colonoscopy without a cap.
|
Cap Assisted Colonoscopy
n=561 Participants
A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
|
|---|---|---|
|
Advanced Adenoma Detection Rate
|
49 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: duration of colonoscopyProportion of patients with a bowel preparation that was rated as good or excellent (four point scale that distinguishes the bowel prep as poor, fair, good or excellent).
Outcome measures
| Measure |
Standard Colonoscopy
n=552 Participants
Colonoscopy without a cap.
|
Cap Assisted Colonoscopy
n=561 Participants
A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
|
|---|---|---|
|
Quality of Bowel Preparation
|
518 Participants
|
502 Participants
|
SECONDARY outcome
Timeframe: time of colonoscope withdrawal• Time taken for the withdrawal of the colonoscope from the cecum to anus among patients, who did not have any polyps.
Outcome measures
| Measure |
Standard Colonoscopy
n=552 Participants
Colonoscopy without a cap.
|
Cap Assisted Colonoscopy
n=561 Participants
A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
|
|---|---|---|
|
Withdrawal Time
|
8.9 minutes
Interval 7.4 to 11.2
|
8.4 minutes
Interval 6.7 to 10.2
|
SECONDARY outcome
Timeframe: during colonoscopy• Proportion of patients, for whom intubation of the terminal ileum with the colonoscope was rated as "easy". Intubation could be rated by the endoscopist as "easy", "slightly difficult", "difficult", or "unable to intubate".
Outcome measures
| Measure |
Standard Colonoscopy
n=552 Participants
Colonoscopy without a cap.
|
Cap Assisted Colonoscopy
n=561 Participants
A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
|
|---|---|---|
|
Ease of Terminal Ileum Intubation
|
435 Participants
|
473 Participants
|
SECONDARY outcome
Timeframe: duration of colonoscopyDifference in recommended surveillance interval between real time polyp diagnosis and pathological diagnosis among patients with at least one diminutive polyp
Outcome measures
| Measure |
Standard Colonoscopy
n=269 Participants
Colonoscopy without a cap.
|
Cap Assisted Colonoscopy
n=297 Participants
A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
|
|---|---|---|
|
Real Time Prediction of Polyp Histology
|
246 Participants
|
281 Participants
|
Adverse Events
Standard Colonoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cap 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place