Trial Outcomes & Findings for Effect of Video Monitor Size on Adenoma Detection Rate (NCT NCT01952418)
NCT ID: NCT01952418
Last Updated: 2017-05-30
Results Overview
Number of patients with adenoma detected
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1805 participants
Primary outcome timeframe
within 2 weeks (range of 1 day-14 days) of the endoscopy
Results posted on
2017-05-30
Participant Flow
Participant milestones
| Measure |
Standard Monitor (24")
Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24").
|
Large Monitor (32")
Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32").
|
|---|---|---|
|
Overall Study
STARTED
|
910
|
895
|
|
Overall Study
COMPLETED
|
910
|
895
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Video Monitor Size on Adenoma Detection Rate
Baseline characteristics by cohort
| Measure |
Standard Monitor (24")
n=910 Participants
Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24").
|
Large Monitor (32")
n=895 Participants
Endoscopists in this arm will perform colonoscopy using the large size video monitor (32").
|
Total
n=1805 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
55.8 years
STANDARD_DEVIATION 11.5 • n=107 Participants
|
55.3 years
STANDARD_DEVIATION 11.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
521 Participants
n=99 Participants
|
498 Participants
n=107 Participants
|
1019 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
389 Participants
n=99 Participants
|
397 Participants
n=107 Participants
|
786 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
910 participants
n=99 Participants
|
895 participants
n=107 Participants
|
1805 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: within 2 weeks (range of 1 day-14 days) of the endoscopyPopulation: all indications
Number of patients with adenoma detected
Outcome measures
| Measure |
Standard Monitor (24")
n=910 Participants
Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24").
|
Large Monitor (32")
n=895 Participants
Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32").
|
|---|---|---|
|
Adenoma Detection Rate (All Indications)
|
264 Participants
|
271 Participants
|
PRIMARY outcome
Timeframe: within 2 weeks (range of 1 day-14 days) of the endoscopyPopulation: screening exams only
Number of patients with adenoma detected
Outcome measures
| Measure |
Standard Monitor (24")
n=491 Participants
Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24").
|
Large Monitor (32")
n=522 Participants
Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32").
|
|---|---|---|
|
Adenoma Detection Rate (Screening Exams Only)
|
137 Participants
|
157 Participants
|
SECONDARY outcome
Timeframe: recorded during endoscopy (immediate)Population: all indications
Number of patients with polyps detected
Outcome measures
| Measure |
Standard Monitor (24")
n=910 Participants
Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24").
|
Large Monitor (32")
n=895 Participants
Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32").
|
|---|---|---|
|
Polyp Detection Rate (All Indications)
|
367 Participants
|
424 Participants
|
SECONDARY outcome
Timeframe: recorded during endoscopy (immediate)Population: screening exams only
Number of patients with polyps detected
Outcome measures
| Measure |
Standard Monitor (24")
n=491 Participants
Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24").
|
Large Monitor (32")
n=522 Participants
Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32").
|
|---|---|---|
|
Polyp Detection Rate (Screening Exams Only)
|
137 Participants
|
157 Participants
|
Adverse Events
Standard Monitor (24")
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Large Monitor (32")
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