Trial Outcomes & Findings for Study Comparing Blue Light Imaging (BLI) With Flexible Spectral-Imaging Color Enhancement (FICE) (NCT NCT02755285)

Last Updated: 2020-06-04

Results Overview

Likert score ratings of image quality for Blue Light Imaging (BLI), Blue Light Imaging-bright (BLI-brt) and Flexible spectral-Imaging Color Enhancement (FICE) images. Each BLI and BLI-Brt setting was compared to FICE, to determine which settings were equivalent to FICE. Likert Score Scale: 1. Not seen; 2. poor but usable, characteristic features are detectable but details are not fully reproduced; features just visible; 3. good; allows an adequate assessment, details of anatomical structures are visible but not necessarily clearly defined; details emerging; 4. very good; allows an excellent assessment, anatomical details are clearly defined; details clear This was a blinded and randomized Reader assessment of all BLI and FICE images.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Two to three months

Results posted on

2020-06-04

Participant Flow

Subjects enrolled had been referred to Mayo Clinic for clinically indicated gastrointestinal diagnostic endoscopy between August 19, 2016 and September 7, 2016.

Each subject underwent a complete diagnostic endoscopy examination with white light, followed by an exam with BLI (BLI + BLI-brt) and FICE, at 3 FICE settings (1,2 \& 6). Each subject could contribute up to 2 anatomical sites (regions of interest).

Participant milestones

Participant milestones
Measure	Single Endoscopy Procedure All subjects will have 1 endoscopy procedure, in which they will have a white light examination followed by FICE and BLI imaging on a maximum of two (2) anatomical sites per subject. Single Endoscopy Procedure: All subjects will have 1 endoscopy procedure, in which they will have a white light examination followed by FICE and BLI imaging on a maximum of two (2) anatomical sites per subject.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Comparing Blue Light Imaging (BLI) With Flexible Spectral-Imaging Color Enhancement (FICE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Endoscopy Procedure n=20 Participants All subjects will have 1 endoscopy procedure, in which they will have a white light examination followed by FICE and BLI imaging on a maximum of two (2) anatomical sites per subject. Single Endoscopy Procedure: All subjects will have 1 endoscopy procedure, in which they will have a white light examination followed by FICE and BLI imaging on a maximum of two (2) anatomical sites per subject.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Age, Continuous	58.6 years n=99 Participants
Sex: Female, Male Female	11 Participants n=99 Participants
Sex: Female, Male Male	9 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	20 participants n=99 Participants

PRIMARY outcome

Timeframe: Two to three months

Population: All patients had imaging done with white light (standard) as well as BLI, BLI-brt, and FICE. Each of the three (3) Readers had a unique set of randomized images which they reviewed independently during the reader study.

Outcome measures

Outcome measures
Measure	Single Endoscopy Procedure n=20 Participants All subjects will have 1 endoscopy procedure, in which they will have a white light examination followed by FICE and BLI imaging on a maximum of two (2) anatomical sites per subject.
Image Quality Scores Using Likert Scale BLI	3.3 units on a scale Standard Deviation 0.2
Image Quality Scores Using Likert Scale BLI-brt	3.5 units on a scale Standard Deviation 0.1
Image Quality Scores Using Likert Scale FICE Setting 1	3.4 units on a scale Standard Deviation 0.1
Image Quality Scores Using Likert Scale FICE Setting 2	3.5 units on a scale Standard Deviation 0.1
Image Quality Scores Using Likert Scale FICE Setting 6	3.5 units on a scale Standard Deviation 0.0

Adverse Events

Single Endoscopy Procedure

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

Randy Vader

Fujifilm Medical Systems USA, Inc.

Phone: (360) 356-6821

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place