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

NCT02755285 | Completed Results FDA Device

• 1 other identifier: P-16-004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endoscopy

Keywords

BLI; FICE

Outcome Measures

Primary Outcomes (1)

• 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: 1. Not seen; 2. poor but usable, characteristic features are detectable but details are not fully reproduced; features just visible; 3. good; allows an adequate assessment, details of anatomical structures are visible but not necessarily clearly defined; details emerging; 4. 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

Study Arms (1)

Single Endoscopy Procedure

EXPERIMENTAL

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

Interventions

Single Endoscopy Procedure DEVICE

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.

Single Endoscopy Procedure

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Fujifilm Medical Systems USA, Inc.: lead

Study Sites (1)

Mayo Clinic AZ

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Randy Vader
• Organization: Fujifilm Medical Systems USA, Inc.

randy.vader@fujifilm.com

(360) 356-6821

Study Officials

• Aiji Matsunuma

  FUJIFILM Medical Systems, U.S.A., Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 28, 2016
• Study Start: August 18, 2016
• Primary Completion: September 23, 2016
• Study Completion: October 9, 2016
• Last Updated: June 4, 2020
• Results First Posted: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)