Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim
Primary Purpose
Gastro-Intestinal Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fuji Flim Processor VP-7000, Light Source BL-7000
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastro-Intestinal Disorder focused on measuring endoscopic image, Fujifilm, Blue light imaging
Eligibility Criteria
Inclusion Criteria:
- Inflammatory bowel disease
- Screening colonoscopy
- Barrett's esophagus
- Colon polyps
- Celiac disease
Exclusion Criteria:
- Platelet count <50,000
- Unwilling to provide informed consent
Sites / Locations
- Mayo Clinic in Florida
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fuji Flim Processor VP-7000
Arm Description
Screening or surveillance colonoscopy using Fuji Flim Processor VP-7000, Light Source BL-7000
Outcomes
Primary Outcome Measures
Number of Subjects Whose Endoscopic Images Correlated With Final Clinical and Histological Diagnosis
Subjects presenting with gastrointestinal mucosal disorders will have a biopsy based on clinical standard of care. Just prior to the biopsy, a standard set of electronic images will be captured using the Fujifilm 7000 Blue Light Imaging System with 4-LED Multi Light Technology. Images will be correlated with the final clinical and histological diagnosis of the gastrointestinal disorder.
Secondary Outcome Measures
Full Information
NCT ID
NCT03440047
First Posted
December 1, 2017
Last Updated
September 29, 2023
Sponsor
Mayo Clinic
Collaborators
Fujifilm Medical Systems USA, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03440047
Brief Title
Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim
Official Title
Minimal Risk Registry of Endoscopic Image and Pathology Correlation Using Fujifilm 7000 Blue Light Imaging System With 4 Light-emitting Diode (LED) Multi Light Technology
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
December 5, 2022 (Actual)
Study Completion Date
March 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Fujifilm Medical Systems USA, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to see if advanced endoscopic imaging may be helpful to accurately distinguish pathological tissue from normal tissue and guide therapy of endoscopically identified pathology.
Detailed Description
In this registry, the Fujifilm 4-LED system, which is considered non significant risk, will be used for routine endoscopic procedures at Mayo Clinic Florida and Rochester. Where indicated and based on clinical standards of care, a biopsy or tissue removal will be performed. Immediately prior to tissue removal, a standard set of electronic images will be captured including white light, BLI, BLI-bright, LCI. Each image will be stored in high resolution lossless format and later correlated with the final clinical and histological diagnosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-Intestinal Disorder
Keywords
endoscopic image, Fujifilm, Blue light imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Registry of endoscopic image and pathology correlation of different pathological condition such as: inflammatory bowel disease, colon polyps
Masking
None (Open Label)
Allocation
N/A
Enrollment
355 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fuji Flim Processor VP-7000
Arm Type
Experimental
Arm Description
Screening or surveillance colonoscopy using Fuji Flim Processor VP-7000, Light Source BL-7000
Intervention Type
Device
Intervention Name(s)
Fuji Flim Processor VP-7000, Light Source BL-7000
Intervention Description
Fujifilm's Digital Video Processor VP-7000 and LED Light Source BL-7000 is a class II Endoscopic Video Imaging System under 21 C.F.R. 876.1500. It is the next generation of Fujifilm's VP-4440HD Digital Video Processor with Flexible-spectral Imaging Color Enhancement (FICE) and Light Source (K140149).
Primary Outcome Measure Information:
Title
Number of Subjects Whose Endoscopic Images Correlated With Final Clinical and Histological Diagnosis
Description
Subjects presenting with gastrointestinal mucosal disorders will have a biopsy based on clinical standard of care. Just prior to the biopsy, a standard set of electronic images will be captured using the Fujifilm 7000 Blue Light Imaging System with 4-LED Multi Light Technology. Images will be correlated with the final clinical and histological diagnosis of the gastrointestinal disorder.
Time Frame
Approximately one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients age 18-100 undergoing planned upper or lower endoscopy at Mayo Clinic Rochester
Informed Consent
Exclusion Criteria:
1. Patient unwilling to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nayantara Coelho-Prabhu, MBBS
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim
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