N/A
Completed N=20
Study Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)
Routine Endoscopy
Source: ClinicalTrials.gov NCT02005393 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Image Quality Scores Using Likert Scale — 3.2; 3.3; 3.4; 3.3 units on a scale
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.
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 | — |
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
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. Informational only — not medical advice.