N/A N=20 Diagnostic

Study Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)

Routine Endoscopy

Bottom Line

View on ClinicalTrials.gov: NCT02005393 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcome: Primary: Image Quality Scores Using Likert Scale — 3.2; 3.3; 3.4; 3.3 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: FICE Image Acquisition followed by NBI Image Acquisition (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Fujifilm Medical Systems USA, Inc.
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Image Quality Scores Using Likert Scale	3.2; 3.3; 3.4; 3.3; 3.3; 3.1	—

Summary

The study is intended to test the image quality of the FICE system to the predicate device, Narrow Band Imaging (NBI). The hypothesis is the images are of equal quality.

Eligibility Criteria

Inclusion Criteria

Referred for diagnostic endoscopy or colonoscopy
Ability to comply and willingness to partake in study

Exclusion Criteria

less than 21 years of age
is an inmate

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02005393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.