Trial Outcomes & Findings for Study of Flat Polyp Detection Using New Narrow Band Imaging (NBI) Compared to White Light Colonoscopy - The FIND FLAT Colonoscopy Study (NCT NCT01310699)
NCT ID: NCT01310699
Last Updated: 2017-12-06
Results Overview
Compare the nonpolypoid colorectal neoplasm detection characteristics of the new high definition narrow band imaging colonoscopy to conventional high definition white light mode colonoscopy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
281 participants
Primary outcome timeframe
One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
Results posted on
2017-12-06
Participant Flow
Participant milestones
| Measure |
High Definition NBI Colonoscopy
Use of high definition narrow band imaging colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging.
|
High Definition White Light Colonoscopy
Use of high definition white light colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging.
|
|---|---|---|
|
Overall Study
STARTED
|
132
|
149
|
|
Overall Study
COMPLETED
|
128
|
143
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
| Measure |
High Definition NBI Colonoscopy
Use of high definition narrow band imaging colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging.
|
High Definition White Light Colonoscopy
Use of high definition white light colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging.
|
|---|---|---|
|
Overall Study
Patients did not complete tandem.
|
4
|
6
|
Baseline Characteristics
Study of Flat Polyp Detection Using New Narrow Band Imaging (NBI) Compared to White Light Colonoscopy - The FIND FLAT Colonoscopy Study
Baseline characteristics by cohort
| Measure |
High Definition NBI Colonoscopy
n=128 Participants
Use of high definition narrow band imaging colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging.
|
High Definition White Light Colonoscopy
n=143 Participants
Use of high definition white light colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging.
|
Total
n=271 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.7 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
62.3 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
63 years
STANDARD_DEVIATION 9.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
125 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One week (time of procedure plus time for pathology of polyp to be analyzed by histology)Compare the nonpolypoid colorectal neoplasm detection characteristics of the new high definition narrow band imaging colonoscopy to conventional high definition white light mode colonoscopy.
Outcome measures
| Measure |
High Definition NBI Colonoscopy
n=128 Participants
Use of high definition narrow band imaging colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging.
|
High Definition White Light Colonoscopy
n=143 Participants
Use of high definition white light colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging.
|
|---|---|---|
|
Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm
|
33 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: One week (time of procedure plus time for pathology of polyp to be analyzed by histology)Compare the number of missed lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy, based on the tandem colonoscopy findings.
Outcome measures
| Measure |
High Definition NBI Colonoscopy
n=128 Participants
Use of high definition narrow band imaging colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging.
|
High Definition White Light Colonoscopy
n=143 Participants
Use of high definition white light colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging.
|
|---|---|---|
|
Percentage of Missed Lesions on Index Colonoscopy.
|
32.0 percentage of adenomas
|
31.4 percentage of adenomas
|
SECONDARY outcome
Timeframe: One week (time of procedure plus time for pathology of polyp to be analyzed by histology)Population: Adenoma by shape (i.e. Flat)
Compare the number of missed non-polypoid lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy.
Outcome measures
| Measure |
High Definition NBI Colonoscopy
n=128 Participants
Use of high definition narrow band imaging colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging.
|
High Definition White Light Colonoscopy
n=143 Participants
Use of high definition white light colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging.
|
|---|---|---|
|
Percentage of Nonpolypoid (Flat) Missed Lesions
|
7.2 percentage of adenomas
|
11.8 percentage of adenomas
|
Adverse Events
High Definition NBI Colonoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Definition White Light 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