An interventional study of Fuji Flim Processor VP-7000, Light Source BL-7000 in Gastro-Intestinal Disorder, sponsored by Mayo Clinic. Completed at 2 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-10-03.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic
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.
Exclusion Criteria:
Screening or surveillance colonoscopy using Fuji Flim Processor VP-7000, Light Source BL-7000
Device: 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).
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
| Milestone | Fuji Film Processor VP-7000 |
|---|---|
| Started | 355 |
| Completed | 353 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
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 | Fuji Film Processor VP-7000 |
|---|---|
| Number of Subjects Whose Endoscopic Images Correlated With Final Clinical and Histological Diagnosis | 283 |
Collected over Adverse event data collected from endoscopy to either clinical or pathological results return, up to one year.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fuji Film Processor VP-7000 | 0/355 (0%) | 4/355 (1.1%) | 13/355 (3.7%) |
| Event | Fuji Film Processor VP-7000 |
|---|---|
| Abdominal painGastrointestinal disorders | 1/355 |
| StrokeVascular disorders | 1/355 |
| Esophageal PerforationGastrointestinal disorders | 1/355 |
| Gastrointestinal BleedGastrointestinal disorders | 1/355 |
| Gastric ulcersGastrointestinal disorders | 1/355 |
| HematemesisGastrointestinal disorders | 1/355 |
| Event | Fuji Film Processor VP-7000 |
|---|---|
| COVID-19Infections and infestations | 2/355 |
| VomitingGastrointestinal disorders | 2/355 |
| Tooth extractionSurgical and medical procedures | 1/355 |
| Perirectal abscessGastrointestinal disorders | 1/355 |
| Back painMusculoskeletal and connective tissue disorders | 1/355 |
| VasculitisVascular disorders | 1/355 |
| Head injuryInjury, poisoning and procedural complications | 1/355 |
| Fall secondary to syncopeInjury, poisoning and procedural complications | 1/355 |
| Opioid overdoseInjury, poisoning and procedural complications | 1/355 |
| HyperglycemiaEndocrine disorders | 1/355 |
| Age, Continuous(years) | Fuji Film Processor VP-7000 |
|---|---|
| Mean | 59.7 (20 to 90) |
| Sex: Female, Male(Participants) | Fuji Film Processor VP-7000 |
|---|---|
| Female | 154 |
| Male | 201 |
| Ethnicity (NIH/OMB)(Participants) | Fuji Film Processor VP-7000 |
|---|---|
| Hispanic or Latino | 14 |
| Not Hispanic or Latino | 336 |
| Unknown or Not Reported | 5 |
| Race (NIH/OMB)(Participants) | Fuji Film Processor VP-7000 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 6 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 14 |
| White | 325 |
| More than one race | 2 |
| Unknown or Not Reported | 7 |
| Region of Enrollment(Participants) | Fuji Film Processor VP-7000 |
|---|---|
| United States | 355 |
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