Trials / Completed
CompletedNCT02755285
Study Comparing Blue Light Imaging (BLI) With Flexible Spectral-Imaging Color Enhancement (FICE)
A Concurrence Study of Diagnostic Visualization Comparing Blue Light Imaging (BLI) With Flexible Spectral-Imaging Color Enhancement (FICE)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Fujifilm Medical Systems USA, Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
This clinical study will consist of acquisition of images, followed by a reader study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2016-08-18
- Primary completion
- 2016-09-23
- Completion
- 2016-10-09
- First posted
- 2016-04-28
- Last updated
- 2020-06-04
- Results posted
- 2020-05-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02755285. Inclusion in this directory is not an endorsement.