N/A N=20 Diagnostic

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

Endoscopy

Bottom Line

View on ClinicalTrials.gov: NCT02755285 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2020

Primary outcome: Primary: Image Quality Scores Using Likert Scale — 3.3; 3.5; 3.4; 3.5 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Single Endoscopy Procedure (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Fujifilm Medical Systems USA, Inc.
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Image Quality Scores Using Likert Scale	3.3; 3.5; 3.4; 3.5; 3.5	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02755285). 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.