Study Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)
- Conditions
- Routine Endoscopy
- Interventions
- Device: FICE Image Acquisition followed by NBI Image Acquisition
- Registration Number
- NCT02005393
- Lead Sponsor
- Fujifilm Medical Systems USA, Inc.
- Brief 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.
- Detailed Description
No additional description required.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Referred for diagnostic endoscopy or colonoscopy
- Ability to comply and willingness to partake in study
- less than 21 years of age
- is an inmate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FICE Imaging System followed by NBI FICE Image Acquisition followed by NBI Image Acquisition Images Captured with FICE Image Acquisition System (experimental) followed by NBI Image Acquisition System (standard of care); always in that order. Imaging took place in esophagus, gastric, duodenum and/or colon.
- Primary Outcome Measures
Name Time Method Image Quality Scores Using Likert Scale One day Likert score ratings of image quality for FICE and NBI images. Each FICE setting was compared to NBI, to determine which FICE settings were equivalent to NBI.
Likert Scores:
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 assesssment, anatomical details are clearly defined; details clear
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic, Arizona
🇺🇸Scottsdale, Arizona, United States