Trial Outcomes & Findings for Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments (NCT NCT02665741)
NCT ID: NCT02665741
Last Updated: 2020-06-18
Results Overview
The investigators will compare adenoma detection rate at completion of study across the 3 arms
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
126 participants
Primary outcome timeframe
Completion of procedure
Results posted on
2020-06-18
Participant Flow
Participant milestones
| Measure |
Control
No distal colonoscope attachment will be used in this arm
Control: No distal colonoscope attachments
|
Olympus Transparent Cap
The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure
Olympus transparent cap: distal colonoscope attachment
|
Medivators Endocuff
The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure
Medivators Endocuff: distal colonoscope attachment
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
42
|
|
Overall Study
COMPLETED
|
42
|
42
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Colon Adenoma Detection Rate Using Two Distal Colonoscope Attachments
Baseline characteristics by cohort
| Measure |
Control
n=42 Participants
No distal colonoscope attachment will be used in this arm
Control: No distal colonoscope attachments
|
Olympus Transparent Cap
n=42 Participants
The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure
Olympus transparent cap: distal colonoscope attachment
|
Medivators Endocuff
n=42 Participants
The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure
Medivators Endocuff: distal colonoscope attachment
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.3 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
60.0 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
60 years
STANDARD_DEVIATION 8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Smoking status
Never Smoker
|
30 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Smoking status
Former Smoker
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Smoking status
Current Smoker
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Alcoholic drinks per week
|
4.0 drinks per week
STANDARD_DEVIATION 3.6 • n=5 Participants
|
6.8 drinks per week
STANDARD_DEVIATION 10.7 • n=7 Participants
|
4.4 drinks per week
STANDARD_DEVIATION 4.0 • n=5 Participants
|
5.07 drinks per week
STANDARD_DEVIATION 6.97 • n=4 Participants
|
|
Diabetes
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
BMI
|
28.5 kg/m^2
STANDARD_DEVIATION 4.3 • n=5 Participants
|
28.3 kg/m^2
STANDARD_DEVIATION 5.5 • n=7 Participants
|
27.4 kg/m^2
STANDARD_DEVIATION 5.4 • n=5 Participants
|
28.07 kg/m^2
STANDARD_DEVIATION 5.08 • n=4 Participants
|
PRIMARY outcome
Timeframe: Completion of procedureThe investigators will compare adenoma detection rate at completion of study across the 3 arms
Outcome measures
| Measure |
Control
n=42 Participants
No distal colonoscope attachment will be used in this arm
Control: No distal colonoscope attachments
|
Olympus Transparent Cap
n=42 Participants
The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure
Olympus transparent cap: distal colonoscope attachment
|
Medivators Endocuff
n=42 Participants
The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure
Medivators Endocuff: distal colonoscope attachment
|
|---|---|---|---|
|
Adenoma Detection Rate
|
52.4 percentage of adenomas detected
|
40.5 percentage of adenomas detected
|
54.8 percentage of adenomas detected
|
SECONDARY outcome
Timeframe: Completion of procedureThe investigators will compare proximal adenoma detection rate at completion of study across the 3 arms
Outcome measures
| Measure |
Control
n=42 Participants
No distal colonoscope attachment will be used in this arm
Control: No distal colonoscope attachments
|
Olympus Transparent Cap
n=42 Participants
The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure
Olympus transparent cap: distal colonoscope attachment
|
Medivators Endocuff
n=42 Participants
The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure
Medivators Endocuff: distal colonoscope attachment
|
|---|---|---|---|
|
Proximal Adenoma Detection Rate
|
45.2 percentage of proximal adenomas
|
35.7 percentage of proximal adenomas
|
50.0 percentage of proximal adenomas
|
SECONDARY outcome
Timeframe: Completion of procedureThe investigators will compare cecal intubation rate at completion of study across the 3 arms
Outcome measures
| Measure |
Control
n=42 Participants
No distal colonoscope attachment will be used in this arm
Control: No distal colonoscope attachments
|
Olympus Transparent Cap
n=42 Participants
The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure
Olympus transparent cap: distal colonoscope attachment
|
Medivators Endocuff
n=42 Participants
The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure
Medivators Endocuff: distal colonoscope attachment
|
|---|---|---|---|
|
Cecal Intubation Rate
|
100 percentage of cecal intubation
|
100 percentage of cecal intubation
|
100 percentage of cecal intubation
|
SECONDARY outcome
Timeframe: Completion of procedureThe investigators will compare colonoscopy withdrawal time rate at completion of study across the 3 arms
Outcome measures
| Measure |
Control
n=42 Participants
No distal colonoscope attachment will be used in this arm
Control: No distal colonoscope attachments
|
Olympus Transparent Cap
n=42 Participants
The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure
Olympus transparent cap: distal colonoscope attachment
|
Medivators Endocuff
n=42 Participants
The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure
Medivators Endocuff: distal colonoscope attachment
|
|---|---|---|---|
|
Withdrawal Time
|
12.9 minutes
Standard Deviation 5.2
|
12.4 minutes
Standard Deviation 5.6
|
13.0 minutes
Standard Deviation 6.2
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Olympus Transparent Cap
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Medivators Endocuff
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=42 participants at risk
Standard colonoscopy - no distal colonoscope attachment will be used in this arm
Control: No distal colonoscope attachments
|
Olympus Transparent Cap
n=42 participants at risk
The Olympus transparent cap will be attached to the distal end of colonoscope prior to starting the procedure
Olympus transparent cap: distal colonoscope attachment
|
Medivators Endocuff
n=42 participants at risk
The Medivators Endocuff will be attached to the distal end of colonoscope prior to starting the procedure
Medivators Endocuff: distal colonoscope attachment
|
|---|---|---|---|
|
Gastrointestinal disorders
Bleeding
|
0.00%
0/42 • 8 months
|
0.00%
0/42 • 8 months
|
4.8%
2/42 • Number of events 2 • 8 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place