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.
406 studies on the registry are indexed under Digestive System Diseases; 79 are open to participants now.
This study's enrollment of 355 is above the median of 85 across 288 interventional studies indexed under Digestive System Diseases.
Browse Digestive System Diseases studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
Plan to share: No
Ran from Aug 2017 to primary completion in Dec 2022, 63 months.
Results were first posted in Oct 2023, 9 months after primary completion.
Of 63 non-industry interventional studies with no phase under Digestive System Diseases, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 63. This study's 63 months is above that.
Counting every sponsor, half of 77 studies reached it within 21 months; a quarter within 6 and three quarters within 57.
Digestive System Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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