Gastro-Intestinal DisorderNCT03440047
Minimal Risk Registry of Endoscopic Image and Pathology Correlation for Fujiflim
A study testing Fuji Flim Processor VP-7000, Light Source BL-7000 in people with Gastro-Intestinal Disorder, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Gastro-Intestinal Disorder
- What is being tested?
- Fuji Flim Processor VP-7000, Light Source BL-7000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Aug 2017to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients age 18-100 undergoing planned upper or lower endoscopy at Mayo Clinic Rochester
- Informed Consent
Who cannot join
- 1. Patient unwilling to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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
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.
Read the 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.
- Conditions
- Gastro-Intestinal Disorder
- Being tested
- Fuji Flim Processor VP-7000, Light Source BL-7000
- Keywords
- endoscopic image, Fujifilm, Blue light imaging
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuji Flim Processor VP-7000, Light Source BL-7000Device
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).
| Study group | Role | What they receive |
|---|---|---|
| Fuji Flim Processor VP-7000 | Experimental | Screening or surveillance colonoscopy using Fuji Flim Processor VP-7000, Light Source BL-7000 Receives: Device: Fuji Flim Processor VP-7000, Light Source BL-7000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start28 Aug 2017
- Primary completion5 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastro-Intestinal DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Registry of endoscopic image and pathology correlation of different pathological condition such as: inflammatory bowel disease, colon polyps
- Masking
- None (open label)
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Fujifilm Medical Systems USA, Inc.
- Responsible party
- Principal investigator, Nayantara Coelho-Prabhu, Mayo Clinic
- Investigators
- Nayantara Coelho-Prabhu, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440047
- Sponsor's protocol ID
- 17-002101
- Status last verified
- Sep 2023
- First submitted
- 1 Dec 2017
- Last updated
- 3 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03440047
- Acronym / sponsor ID
- 17-002101
- Conditions
- Gastro-Intestinal Disorder
- Keywords
- endoscopic image, Fujifilm, Blue light imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Fujifilm Medical Systems USA, Inc.
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 20 Feb 2018 (actual)
- Results
- Posted 3 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Registry of endoscopic image and pathology correlation of different pathological condition such as: inflammatory bowel disease, colon polyps
| Arm | Type | Receives |
|---|---|---|
| Fuji Flim Processor VP-7000 | Experimental | Device: Fuji Flim Processor VP-7000, Light Source BL-7000Screening or surveillance colonoscopy using Fuji Flim Processor VP-7000, Light Source BL-7000 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients age 18-100 undergoing planned upper or lower endoscopy at Mayo Clinic Rochester
- Informed Consent
Key exclusion criteria (1 listed)
- 1. Patient unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fuji Flim Processor VP-7000, Light Source BL-7000Fujifilm'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). | Device | Fuji Flim Processor VP-7000 |
Primary outcome
Number of Subjects Whose Endoscopic Images Correlated With Final Clinical and Histological Diagnosis
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayantara Coelho-Prabhu, MBBS principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fuji Flim Processor VP-7000, Light Source BL-7000 in people with Gastro-Intestinal Disorder, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Whose Endoscopic Images Correlated With Final Clinical and Histological Diagnosis (time frame: Approximately one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.