Colorectal CancerCOLOWISENCT05611151
Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy
A study testing Computer Aided Detection (CADe) in people with Colorectal Cancer and Adenoma Colon, run by NEC Corporation at 5 sites in 4 countries.
Trial summary
This is a prospective, multicenter, randomized study to evaluate the clinical performance of a novel CADe device, WISE VISION® Endoscopy System, in patients undergoing high-definition white light (HDWL) colonoscopy for screening or surveillance of colorectal Cancer (CRC). Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Colorectal Cancer, Adenoma Colon, Polyp of Colon
- What is being tested?
- Computer Aided Detection (CADe)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 830 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 30 Apr 2023to 10 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is presenting to the endoscopy unit for colon cancer screening or surveillance colonoscopy.
- Signed Informed Consent
Who cannot join
- Contraindications to colonoscopy
- Colonoscopy within the previous three (3) years
- High-risk indications for colonoscopy
- Antithrombotic therapy that cannot be stopped, precluding polyp resection
- Inflammatory bowel disease
- Referred for endoscopic mucosal resection (EMR)
- Familial adenomatous polyposis syndrome or Serrated Polyposis Syndrome
- Pregnant or planning a pregnancy during the study period
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Italy2 sites
Humanitas Mater Domini
Castellanza
Humanitas Research Hospital
Milan, 20089
United States1 site
Kansas City VA Hospital
Kansas City, Missouri, 64128
United Kingdom1 site
Portsmouth Hospitals University NHS Trust, Cosham
Portsmouth, PO6 3LY
About this study
Official title: Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy: Prospective, Randomized Clinical Performance Evaluation
This is a prospective, multicenter, randomized study to evaluate the clinical performance of a novel CADe device, WISE VISION® Endoscopy System, in patients undergoing high-definition white light (HDWL) colonoscopy for screening or surveillance of colorectal Cancer (CRC).
Eligible subjects who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to undergo colonoscopy :
- Experimental: CADe colonoscopy procedure with WISE VISION® Endoscopy (CADe Group)
- Control: Standard Colonoscopy without CADe (Standard Colonoscopy Group)
Read the detailed description
This study aims to evaluate whether NEC WISE VISION® Endoscopy enhances the ability to detect mucosal lesions when compared with the current standard-of-care procedure (high-definition white light [HDWL] colonoscopy). The CADe device, Wise VISION® Endoscopy, contains an artificial intelligence/machine learning (AI/ML) advanced algorithm to aid the endoscopists in detection of colonic lesions.
This study plans to enrol 830 subjects aged ≥ 45 years and < 75 years, who are scheduled for screening or surveillance colonoscopy.
After review of the inclusion and exclusion criteria, eligible subjects will be randomized in a 1:1 ratio to receive either computer-aided colonoscopy (CADe Group) or standard colonoscopy without CADe (Standard Colonoscopy Group).
All adenomas, that are identified during the colonoscopies, will be removed and biopsied as per standard clinical practice to assess adenoma miss rate, polyp miss rate, adenomas per colonoscopy and other endpoints.
- Conditions
- Colorectal Cancer, Adenoma Colon, Polyp of Colon
- Being tested
- Computer Aided Detection (CADe)
- Keywords
- Screening, Artificial Intelligence
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Aided Detection (CADe)Diagnostic test
Computer-aided detection (CADe) devices are used in conjunction with colonoscopy to aid in the detection of lesions in the gastrointestinal tract.
| Study group | Role | What they receive |
|---|---|---|
| CADe Colonoscopy | Experimental | CADe Colonoscopy: Patient undergoes WISE VISION® Endoscopy CADe colonoscopy Receives: Diagnostic Test: Computer Aided Detection (CADe) |
| HDWL Colonoscopy | Active comparator | HDWL Colonoscopy: Patient undergoes HDWL colonoscopy without CADe Receives: Diagnostic Test: Computer Aided Detection (CADe) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenomas per Colonoscopy (APC)
Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.
Measured: during the procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start30 Apr 2023
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel trial design
- Masking
- None (open label)
- Enrolment
- 830 participants (actual)
Sponsor and investigators
- Lead sponsor
- NEC Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd., Meditrial USA Inc.
- Responsible party
- Sponsor
- Investigators
- Hitoshi Ikeda, Study director, NEC Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611151
- Sponsor's protocol ID
- WV-2022-01
- Acronym
- COLOWISE
- Status last verified
- Sep 2024
- First submitted
- 1 Nov 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Yamada M, Saito Y, Imaoka H, Saiko M, Yamada S, Kondo H, Takamaru H, Sakamoto T, Sese J, Kuchiba A, Shibata T, Hamamoto R. Development of a real-time endoscopic image diagnosis support system using deep learning technology in colonoscopy. Sci Rep. 2019 Oct 8;9(1):14465. doi: 10.1038/s41598-019-50567-5.
PubMed 31594962
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy: Prospective, Randomized Clinical Performance Evaluation
- ClinicalTrials.gov ID
- NCT05611151
- Acronym / sponsor ID
- COLOWISE / WV-2022-01
- Conditions
- Colorectal Cancer, Adenoma Colon, Polyp of Colon
- Keywords
- Screening, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 830 participants (actual)
- Lead sponsor
- NEC CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Meditrial Europe Ltd., Meditrial USA Inc.
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multicenter, randomized study to evaluate the clinical performance of a novel CADe device, WISE VISION® Endoscopy System, in patients undergoing high-definition white light (HDWL) colonoscopy for screening or surveillance of colorectal Cancer (CRC).
Eligible subjects who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to undergo colonoscopy :
- Experimental: CADe colonoscopy procedure with WISE VISION® Endoscopy (CADe Group)
- Control: Standard Colonoscopy without CADe (Standard Colonoscopy Group)
Detailed description
This study aims to evaluate whether NEC WISE VISION® Endoscopy enhances the ability to detect mucosal lesions when compared with the current standard-of-care procedure (high-definition white light [HDWL] colonoscopy). The CADe device, Wise VISION® Endoscopy, contains an artificial intelligence/machine learning (AI/ML) advanced algorithm to aid the endoscopists in detection of colonic lesions.
This study plans to enrol 830 subjects aged ≥ 45 years and < 75 years, who are scheduled for screening or surveillance colonoscopy.
After review of the inclusion and exclusion criteria, eligible subjects will be randomized in a 1:1 ratio to receive either computer-aided colonoscopy (CADe Group) or standard colonoscopy without CADe (Standard Colonoscopy Group).
All adenomas, that are identified during the colonoscopies, will be removed and biopsied as per standard clinical practice to assess adenoma miss rate, polyp miss rate, adenomas per colonoscopy and other endpoints.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel trial design
| Arm | Type | Receives |
|---|---|---|
| CADe Colonoscopy | Experimental | Diagnostic Test: Computer Aided Detection (CADe)CADe Colonoscopy: Patient undergoes WISE VISION® Endoscopy CADe colonoscopy |
| HDWL Colonoscopy | Active comparator | Diagnostic Test: Computer Aided Detection (CADe)HDWL Colonoscopy: Patient undergoes HDWL colonoscopy without CADe |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient is presenting to the endoscopy unit for colon cancer screening or surveillance colonoscopy.
- Signed Informed Consent
Key exclusion criteria (8 listed)
- Contraindications to colonoscopy
- Colonoscopy within the previous three (3) years
- High-risk indications for colonoscopy
- Antithrombotic therapy that cannot be stopped, precluding polyp resection
- Inflammatory bowel disease
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 |
|---|---|---|
| Computer Aided Detection (CADe)Computer-aided detection (CADe) devices are used in conjunction with colonoscopy to aid in the detection of lesions in the gastrointestinal tract. | Diagnostic test | CADe Colonoscopy, HDWL Colonoscopy |
Primary outcome
Adenomas per Colonoscopy (APC)
Time frame: during the procedure/surgery
Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 31594962Yamada M, Saito Y, Imaoka H, Saiko M, Yamada S, Kondo H, Takamaru H, Sakamoto T, Sese J, Kuchiba A, Shibata T, Hamamoto R. Development of a real-time endoscopic image diagnosis support system using deep learning technology in colonoscopy. Sci Rep. 2019 Oct 8;9(1):14465. doi: 10.1038/s41598-019-50567-5.
- Meditrial Clinical Research OrganizationLink 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.
Hitoshi Ikeda study director
NEC Corporation
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer Aided Detection (CADe) in people with Colorectal Cancer and Adenoma Colon, run by NEC Corporation at 5 sites in 4 countries.
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 8 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, United States, Germany, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adenomas per Colonoscopy (APC) (time frame: during the procedure/surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05611151, which also lists 1 linked publication.
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 19 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.