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

FujiFilm

Status: Completed

Conditions: Endoscopy

Treatments: Device: Single Endoscopy Procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT02755285

P-16-004

Details and patient eligibility

About

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.

Full description

This clinical study will consist of acquisition of images, followed by a reader study.

Enrollment: 20 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Single Endoscopy Procedure

Experimental group

Description:

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.

Treatment:

Device: Single Endoscopy Procedure