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| Name | Class |
|---|---|
| Fujifilm Medical Systems USA, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fuji Flim Processor VP-7000 | Experimental | Screening or surveillance colonoscopy using Fuji Flim Processor VP-7000, Light Source BL-7000 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fuji Flim Processor VP-7000, Light Source BL-7000 | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately one year |
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Inclusion Criteria:
Exclusion Criteria:
1. Patient unwilling to provide informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Nayantara Coelho-Prabhu, MBBS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States | ||
| Mayo Clinic in Rochester |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants with available histopathological [or other clinical results] to correlate with the images collected endoscopically | Posted | Number | participants | Approximately one year |
|
Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tooth extraction | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nayantara Coelho-Prabhu | Mayo Clinic | (507)284-2407 | CoelhoPrabhu.Nayantara@mayo.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 15, 2021 | Sep 29, 2023 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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Registry of endoscopic image and pathology correlation of different pathological condition such as: inflammatory bowel disease, colon polyps
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|
| Rochester |
| Minnesota |
| 55905 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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|
|
| 0 |
| 355 |
| 4 |
| 355 |
| 13 |
| 355 |
| Stroke | Vascular disorders | Non-systematic Assessment |
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| Esophageal Perforation | Gastrointestinal disorders | Non-systematic Assessment |
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| Gastrointestinal Bleed | Gastrointestinal disorders | Non-systematic Assessment |
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| Gastric ulcers | Gastrointestinal disorders | Non-systematic Assessment |
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| Hematemesis | Gastrointestinal disorders | Non-systematic Assessment |
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| Perirectal abscess | Gastrointestinal disorders | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Vasculitis | Vascular disorders | Non-systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fall secondary to syncope | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Opioid overdose | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Hyperglycemia | Endocrine disorders | Non-systematic Assessment |
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| Clostridium difficile | Infections and infestations | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
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