Trial Outcomes & Findings for Colonoscope Insertion Trial Protocol (NCT NCT01324882)
NCT ID: NCT01324882
Last Updated: 2017-12-02
Results Overview
The time in seconds that it required to intubate the cecum as defined in our protocol.
COMPLETED
NA
57 participants
The outcome was measured during the colonoscopy which was Day 1. The duration of the study was the colonoscopy on Day 1. Once the colonoscopy was finished, the study was over.
2017-12-02
Participant Flow
Patients were recruited from study initiation 1/31/2011 until June 30,2011. Patients were recruited from the clinic.
No details to report
Participant milestones
| Measure |
Study Arm
This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
|
Control
This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
30
|
|
Overall Study
COMPLETED
|
27
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Colonoscope Insertion Trial Protocol
Baseline characteristics by cohort
| Measure |
Study Arm
n=27 Participants
This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
|
Control
n=30 Participants
This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
55.7 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
56 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
55.85 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
30 participants
n=7 Participants
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The outcome was measured during the colonoscopy which was Day 1. The duration of the study was the colonoscopy on Day 1. Once the colonoscopy was finished, the study was over.The time in seconds that it required to intubate the cecum as defined in our protocol.
Outcome measures
| Measure |
Study Arm
n=27 Participants
This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
|
Control
n=30 Participants
This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
|
|---|---|---|
|
Time to Intubate the Cecum
|
271 seconds
Standard Deviation 196
|
403 seconds
Standard Deviation 148
|
PRIMARY outcome
Timeframe: (day 1) Within time for performance of colonoscopyThe ability of endoscopist to intubate the cecum with enough control of the tip to abut the appendix or begin to retroflex in the cecum.
Outcome measures
| Measure |
Study Arm
n=27 Participants
This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
|
Control
n=30 Participants
This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
|
|---|---|---|
|
Intubation of Cecum
|
27 Participants
|
29 Participants
|
Adverse Events
Study Arm
Control
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