Colorectal CancerEuroCADeNCT05943288
Safety and Efficacy of the Olympus CADe System in Real-time Colonoscopy
An observational study of Colorectal Cancer, run by Olympus Europe SE & Co. KG at 6 sites in 4 countries.
Trial summary
This is a prospective, multicenter, randomized Trial to assess the safety and efficacy of the Olympus Endoscopy Computer-Aided Detection (CADe) system, OIP-1, in the detection of colorectal neoplasia's during real-time colonoscopy. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- OIP-1
- Type of treatment
- Medical device
- How many people
- 850 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 25 Apr 2023to 31 Jul 2024
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects undergoing a colonoscopy
Who may be able to join
- Signed informed consent
- 45-80 years
- Undergoing colonoscopy for primary CRC screening or postpolypectomy surveillance
Who cannot join
- Lack of informed written consent
- History of CRC or inflammatory bowel disease or polyposis syndrome / familial adenomatous polyposis coli (FAP)
- Prior failed colonoscopy
- multiple historic prior failed colonoscopy due to poor bowel preparation OR
- a single prior failed colonoscopy due to reasons other than poor bowel preparation
- Biopsy/anesthesia/sedation contraindications
- History of radio- and/or chemotherapy
- Concurrent participation in another competing clinical study
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Germany2 sites
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, 40217
Universitätsklinikum Ulm
Ulm, 89081
Spain2 sites
Fundación Biomédica Galicia Sur
Pontevedra, 36071
Hospital Universitari I Politécnic La Fe
Valencia, 46026
About this study
Official title: Safety and Efficacy of the Olympus Endoscopy Computer-Aided Detection (CADe) System in Detection of Colorectal Neoplasia's During Real-time Colonoscopy: A European Prospective, Multicenter, Randomized Controlled Trial (EuroCADe)
This is a prospective, multicenter, randomized Trial to assess the safety and efficacy of the Olympus Endoscopy Computer-Aided Detection (CADe) system, OIP-1, in the detection of colorectal neoplasia's during real-time colonoscopy. The aim of this system is to improve physician performance in the detection of potential mucosal abnormalities during colonoscopy performed for primary Colorectal Cancer screening or postpolypectomy surveillance.
Read the detailed description
This Study aims to provide insight into whether the application of Artificial Intelligence (Olympus Endoscopy Computer-Aided Detection (CADe) system) increases the detection rate of adenomatous polyps in screening and / or surveillance colonoscopy procedures.
- Conditions
- Colorectal Cancer
- Being tested
- OIP-1
- Keywords
- AI (Artificial Intelligence), CADe (Endoscopy Computer Aided Detection)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OIP-1Device
Olympus Endoscopy Computer-Aided Detection (CADe) system
| Study group | Role | What they receive |
|---|---|---|
| CADe + | Olympus Endoscopy Computer-Aided Detection (CADe) system Receives: Device: OIP-1 | |
| CADe - | Standard of Care Endoscopy (HD Whitelight) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate (ADR)
Proportion of patients with at least one histologically confirmed adenoma (including advanced adenomas) or carcinoma in the CADe assisted colonoscopy (CADe+ arm) versus conventional colonoscopy without CAD (CADe- arm).
Measured: During procedure
Positive Predictive Value (PPV)
Number of histologically confirmed polyps (i.e. adenomas, SSLs, or large (>10mm) hyperplastic polyps divided by the total number of resections.
Measured: During procedure
Secondary outcomes (3)
Adenoma Per Colonoscopy (APC)
Number of histologically proven adenomas (including advanced adenomas) or carcinomas divided by the total number of colonoscopies
Measured: During procedure
Total Procedure Time
Time from procedure start (insertion of the colonoscope) until colon inspection during a typical withdrawal from cecum to rectosigmoid including any time needed for interventional procedures (biopsies, resection).
Measured: During procedure
Endoscope withdrawal time
Time from deepest point of insertion (cecum) needed for complete inspection of the colon, excluding time spent on therapeutic intervention.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start25 Apr 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olympus Europe SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cromsource
- Responsible party
- Sponsor
- Investigators
- Karolin Boecker, Study director, Olympus Europa SE & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943288
- Sponsor's protocol ID
- CIP2021-AI (OEKG)-01
- Acronym
- EuroCADe
- Status last verified
- Mar 2025
- First submitted
- 7 Jun 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Olympus Endoscopy Computer-Aided Detection (CADe) System in Detection of Colorectal Neoplasia's During Real-time Colonoscopy: A European Prospective, Multicenter, Randomized Controlled Trial (EuroCADe)
- ClinicalTrials.gov ID
- NCT05943288
- Acronym / sponsor ID
- EuroCADe / CIP2021-AI (OEKG)-01
- Conditions
- Colorectal Cancer
- Keywords
- AI (Artificial Intelligence), CADe (Endoscopy Computer Aided Detection)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Olympus Europe SE & Co. KGIndustry (pharma, biotech, devices)
- Collaborators
- Cromsource
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 13 Jul 2023 (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 Trial to assess the safety and efficacy of the Olympus Endoscopy Computer-Aided Detection (CADe) system, OIP-1, in the detection of colorectal neoplasia's during real-time colonoscopy. The aim of this system is to improve physician performance in the detection of potential mucosal abnormalities during colonoscopy performed for primary Colorectal Cancer screening or postpolypectomy surveillance.
Detailed description
This Study aims to provide insight into whether the application of Artificial Intelligence (Olympus Endoscopy Computer-Aided Detection (CADe) system) increases the detection rate of adenomatous polyps in screening and / or surveillance colonoscopy procedures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CADe + | – | Device: OIP-1Olympus Endoscopy Computer-Aided Detection (CADe) system |
| CADe - | – | –Standard of Care Endoscopy (HD Whitelight) |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing a colonoscopy
Key inclusion criteria (3 listed)
- Signed informed consent
- 45-80 years
- Undergoing colonoscopy for primary CRC screening or postpolypectomy surveillance
Key exclusion criteria (8 listed)
- Lack of informed written consent
- History of CRC or inflammatory bowel disease or polyposis syndrome / familial adenomatous polyposis coli (FAP)
- Prior failed colonoscopy
- Biopsy/anesthesia/sedation contraindications
- History of radio- and/or chemotherapy
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 |
|---|---|---|
| OIP-1Olympus Endoscopy Computer-Aided Detection (CADe) system | Device | CADe + |
Primary outcome
Adenoma Detection Rate (ADR)
Time frame: During procedure
Proportion of patients with at least one histologically confirmed adenoma (including advanced adenomas) or carcinoma in the CADe assisted colonoscopy (CADe+ arm) versus conventional colonoscopy without CAD (CADe- arm).
Positive Predictive Value (PPV)
Time frame: During procedure
Number of histologically confirmed polyps (i.e. adenomas, SSLs, or large (>10mm) hyperplastic polyps divided by the total number of resections.
3 secondary outcomes
Adenoma Per Colonoscopy (APC)
Time frame: During procedure
Total Procedure Time
Time frame: During procedure
Endoscope withdrawal time
Time frame: During procedure
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 18 Mar 2025.
- 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.
Karolin Boecker study director
Olympus Europa SE & Co. KG
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Olympus Europe SE & Co. KG at 6 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 3 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 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Spain, Belgium, Sweden. 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?
Adenoma Detection Rate (ADR) (time frame: During procedure). The study lists 2 primary outcomes in all. 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 18 Mar 2025.