Trial Outcomes & Findings for Clinical Evaluation of Narrow Band Imaging Colonoscope (NCT NCT00628147)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

284 participants

Primary outcome timeframe

same day

Results posted on

2017-03-08

Participant Flow

Participant milestones

Participant milestones
Measure	Narrow Band Imaging Colonoscope Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.	White Light Conventional White Light Examination
Overall Study STARTED	142	142
Overall Study COMPLETED	135	141
Overall Study NOT COMPLETED	7	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of Narrow Band Imaging Colonoscope

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Narrow Band Imaging Colonoscope n=142 Participants Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.	White Light n=142 Participants Conventional White Light Examination	Total n=284 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 10 • n=5 Participants	64 years STANDARD_DEVIATION 10 • n=7 Participants	64 years STANDARD_DEVIATION 10 • n=5 Participants
Gender Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Gender Male	137 Participants n=5 Participants	138 Participants n=7 Participants	275 Participants n=5 Participants

PRIMARY outcome

Timeframe: same day

Outcome measures

Outcome measures
Measure	Narrow Band Imaging Colonoscope n=135 Participants Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.	White Light n=141 Participants Conventional White Light Examination
Neoplasm Miss Rate	12.6 Miss rate percentage Interval 7.5 to 19.4	12.1 Miss rate percentage Interval 7.2 to 18.6

SECONDARY outcome

Timeframe: same day

Population: We report overall neoplasia detection rate, and then report a sub-analysis for the neoplasia detection rates by indication (screening vs non-screening).

Outcome measures

Outcome measures
Measure	Narrow Band Imaging Colonoscope n=135 Participants Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.	White Light n=141 Participants Conventional White Light Examination
Neoplasm Detection Rates Overall	69 Participants	66 Participants
Neoplasm Detection Rates Screening	29 Participants	31 Participants
Neoplasm Detection Rates Non-Screening	40 Participants	35 Participants

SECONDARY outcome

Timeframe: same day

Outcome measures

Outcome measures
Measure	Narrow Band Imaging Colonoscope n=135 Participants Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.	White Light n=141 Participants Conventional White Light Examination
Completion of Examinations	135 Participants	141 Participants

SECONDARY outcome

Timeframe: procedure and post-procedure complications within 30 days after colonoscopy

Outcome measures

Outcome measures
Measure	Narrow Band Imaging Colonoscope n=135 Participants Narrow band imaging colonoscope (CF-H180AL, CF-Q180AL, Evis Exera II CV-180): Adult colonoscopes with narrow band imaging capabilities (XCF-H160AY2L and XCF-Q160W6L, Olympus Medical Systems Corporation, Hachioji, Japan). There is an automatic switch on the handle of the endoscope that allows the physician to instantly switch between narrow band imaging and standard full spectrum white light modes.	White Light n=141 Participants Conventional White Light Examination
Procedure Complications	0 Participants	0 Participants

Adverse Events

Narrow Band Imaging Colonoscope

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

White Light

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

Dr. Tonya Kaltenbach

SF VA Medical Center

Phone: 415-221-4810

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place