Study Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)

FujiFilm

Status: Completed

Conditions: Routine Endoscopy

Treatments: Device: FICE Image Acquisition followed by NBI Image Acquisition

Study type: Interventional

Funder types: Industry

Identifiers

NCT02005393

P-13-003

Details and patient eligibility

About

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.

Full description

No additional description required.

Enrollment: 20 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Referred for diagnostic endoscopy or colonoscopy
• Ability to comply and willingness to partake in study

Exclusion criteria

• less than 21 years of age
• is an inmate

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

FICE Imaging System followed by NBI

Other group

Description:

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.

Treatment:

Device: FICE Image Acquisition followed by NBI Image Acquisition