Gastro-Intestinal Disorder
Conditions
Keywords
endoscopic image, Fujifilm, Blue light imaging
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.
Interventions
DEVICEFuji Flim Processor VP-7000, Light Source BL-7000
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).
Sponsors
Fujifilm Medical Systems USA, Inc.
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Registry of endoscopic image and pathology correlation of different pathological condition such as: inflammatory bowel disease, colon polyps
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. All patients age 18-100 undergoing planned upper or lower endoscopy at Mayo Clinic Rochester 2. Informed Consent
Exclusion criteria
1\. Patient unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Whose Endoscopic Images Correlated With Final Clinical and Histological Diagnosis | Approximately one year | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fuji Film Processor VP-7000 Screening or surveillance endoscopy using Fuji Flim Processor VP-7000, Light Source BL-7000
Fuji Flim Processor VP-7000, Light Source BL-7000: 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). | 355 |
| Total | 355 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Fuji Film Processor VP-7000 |
|---|---|
| Age, Continuous | 59.7 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 336 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 325 Participants |
| Region of Enrollment United States | 355 Participants |
| Sex: Female, Male Female | 154 Participants |
| Sex: Female, Male Male | 201 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 355 |
| other Total, other adverse events | 13 / 355 |
| serious Total, serious adverse events | 4 / 355 |
Outcome results
Primary
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.
Time frame: Approximately one year
Population: Participants with available histopathological \[or other clinical results\] to correlate with the images collected endoscopically
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fuji Film Processor VP-7000 | Number of Subjects Whose Endoscopic Images Correlated With Final Clinical and Histological Diagnosis | 283 participants |