Trial Outcomes & Findings for Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy (NCT NCT01917513)
NCT ID: NCT01917513
Last Updated: 2018-01-23
Results Overview
The percentage of patients with at least one adenoma or serrated lesion in the G-EYE™ group will be compared to the Standard group
COMPLETED
NA
1000 participants
Approximalty following 14 days (histology results)
2018-01-23
Participant Flow
Participant milestones
| Measure |
Standard Colonoscopy
Patients in this group underwent standard high definition colonoscopy
|
G-EYE™ Colonoscopy
Patients in this group underwent G-EYE™ high definition colonoscopy using using an insufflated balloon during withdrawal
|
|---|---|---|
|
Overall Study
STARTED
|
502
|
498
|
|
Overall Study
COMPLETED
|
407
|
396
|
|
Overall Study
NOT COMPLETED
|
95
|
102
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy
Baseline characteristics by cohort
| Measure |
Standard Colonoscopy
n=396 Participants
Patients in this group underwent standard high definition colonoscopy
|
G-EYE™ Colonoscopy
n=407 Participants
Patients in this group underwent G-EYE™ high definition colonoscopy using using an insufflated balloon during withdrawal
|
Total
n=803 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 8.79 • n=99 Participants
|
65.4 years
STANDARD_DEVIATION 8.92 • n=107 Participants
|
65.3 years
STANDARD_DEVIATION 8.85 • n=206 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=99 Participants
|
204 Participants
n=107 Participants
|
377 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
223 Participants
n=99 Participants
|
203 Participants
n=107 Participants
|
426 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Approximalty following 14 days (histology results)The percentage of patients with at least one adenoma or serrated lesion in the G-EYE™ group will be compared to the Standard group
Outcome measures
| Measure |
Standard Colonoscopy
n=392 Participants
Patients in this group underwent standard high definition colonoscopy
|
G-EYE™ Colonoscopy
n=404 Participants
Patients in this group underwent G-EYE™ high definition colonoscopy using using an insufflated balloon during withdrawal
|
|---|---|---|
|
Detection Rate of Adenomas and Serrated Lesions
|
147 Participants
|
194 Participants
|
SECONDARY outcome
Timeframe: Up to 14 days (histology results)The secondary outcome is a composite-each of the measured parameters will be reported as a single value for each arm
Outcome measures
Outcome data not reported
Adverse Events
G-EYE™ Colonoscopy
Standard Colonoscopy
Serious adverse events
| Measure |
G-EYE™ Colonoscopy
n=502 participants at risk
G-EYE™ colonoscopy
G-EYE™ colonoscopy: G-EYE™ colonoscopy
|
Standard Colonoscopy
n=498 participants at risk
Standard Colonoscopy
Standard Colonoscopy: Standard Colonoscopy
|
|---|---|---|
|
Gastrointestinal disorders
obstructive sigmoid tumor
|
0.20%
1/502
|
0.00%
0/498
|
|
Cardiac disorders
an irregular heart rate and bradycardia prior to the initiation of the procedure
|
0.20%
1/502
|
0.00%
0/498
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place