21 and older, any sex, with Endoscopy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Image Quality Scores Using Likert ScalePrimary· Two to three months
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
BLI
Group
Value
95% CI
Single Endoscopy Procedure
3.3
± 0.2
BLI-brt
Group
Value
95% CI
Single Endoscopy Procedure
3.5
± 0.1
FICE Setting 1
Group
Value
95% CI
Single Endoscopy Procedure
3.4
± 0.1
FICE Setting 2
Group
Value
95% CI
Single Endoscopy Procedure
3.5
± 0.1
FICE Setting 6
Group
Value
95% CI
Single Endoscopy Procedure
3.5
± 0.0
Sponsor's own description
The study is intended to demonstrate substantial equivalence of visualization using BLI to the predicate device, FICE, so as to support the addition of BLI as an adjunct to white light imaging in the company's video processor.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Fujifilm Medical Systems USA, Inc.
Last refreshed: 4 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02755285.