Study Comparing Blue Light Imaging (BLI) With Flexible Spectral-Imaging Color Enhancement (FICE)

Study Overview
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Brief Summary
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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
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This clinical study will consist of acquisition of images, followed by a reader study.

Official Title
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A Concurrence Study of Diagnostic Visualization Comparing Blue Light Imaging (BLI) With Flexible Spectral-Imaging Color Enhancement (FICE)

Conditions
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Endoscopy

Intervention / Treatment
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* Device: Single Endoscopy Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referred for clinically indicated gastrointestinal diagnostic endoscopy Ability to understand the requirements of the study, to provide written informed consent and to comply with the study protocol Ability to understand and provide written authorization for the use and disclosure of protected health information (PHI) per the Health Insurance Portability and Accountability Act (HIPAA) privacy ruling. Exclusion Criteria: Under the age of 21 years Is an inmate (see US Code of Federal Regulations 45 C.F.R. 46.306)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Endoscopy Procedure<br>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. | Device: Single Endoscopy Procedure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality Scores Using Likert Scale | 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: Not seen; poor but usable, characteristic features are detectable but details are not fully reproduced; features just visible; good; allows an adequate assessment, details of anatomical structures are visible but not necessarily clearly defined; details emerging; very good; allows an excellent assessment, anatomical details are clearly defined; details clear This was a blinded and randomized Reader assessment of all BLI and FICE images. | Two to three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BLI, FICE