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

Completed · Not applicable

Conditions studied: Endoscopy

In brief

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.

Key facts

Study ID

NCT02755285

Run by

Fujifilm Medical Systems USA, Inc.

People needed

20

Starts

2016-08-18

Expected to finish

2016-10-09

Last updated by the study team

2020-06-04

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Under the age of 21 years
• Is an inmate (see US Code of Federal Regulations 45 C.F.R. 46.306)

Where it is running

• Mayo Clinic AZ — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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