Colorectal PolypsCADECNCT07171333
Role of Computer-Aided Detection Colonoscopy in Polyp Detection Rate
A study testing Colonoscopy with CADe system in people with Colorectal Polyps, run by Gian Eugenio Tontini at 1 site in Italy.
Trial summary
High-definition (HD) colonoscopy is the gold standard for early diagnosis and treatment of lower gastrointestinal neoplasms, with the adenoma detection rate (ADR) serving as a key quality indicator due to its inverse correlation with colorectal cancer incidence. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyps
- What is being tested?
- Colonoscopy with CADe system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 421 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2023to 30 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 40-80 years, any sex
- Indication for screening, surveillance, or diagnostic colonoscopy (e.g., anemia, abdominal symptoms)
- Written informed consent
Who cannot join
- Previous (even partial) colon resection or colonic stenosis
- Acute diverticulitis within 4 weeks
- Inflammatory bowel disease, familial adenomatous polyposis, or microscopic colitis
- Complete colonoscopy within 5 years
- Inadequate suspension of antithrombotic/antiplatelet therapy (per ESGE guidelines)
- Inability to provide consent
- Inadequate bowel preparation (Boston Bowel Preparation Scale <2 in any segment)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Computer-Aided Detection Colonoscopy in Polyp Detection Rate: an Italian Multi-Center Randomized Study (CADEC)
High-definition (HD) colonoscopy is the gold standard for early diagnosis and treatment of lower gastrointestinal neoplasms, with the adenoma detection rate (ADR) serving as a key quality indicator due to its inverse correlation with colorectal cancer incidence. ADR is influenced by operator expertise, fatigue, and human error, which may be mitigated by advanced imaging technologies such as computer-aided detection (CADe). CADe systems provide real-time visual and auditory alerts for suspected polyps and have been shown to increase ADR, though their effectiveness under different operator conditions (high- vs. low-volume, fatigue-related performance, impact on polyp detection rate [PDR] and withdrawal time) remains unclear. This multicenter, prospective, national, open-label randomized trial (6 Italian centers) will compare HD-Iscan colonoscopy with and without CADe assistance (1:1 allocation), with primary endpoint ADR and secondary endpoints including PDR, withdrawal time, and performance stratified by operator fatigue. Eligible patients (aged 40-80, undergoing screening, surveillance, or diagnostic colonoscopy) will be recruited consecutively, with exclusions for prior colonic resection, recent diverticulitis, inflammatory bowel disease, familial polyposis, inadequate bowel preparation, complete colonoscopy within 5 years, inability to consent, or unsafe ongoing antithrombotic therapy. Colonoscopies will follow ESGE guidelines with standard split-dose PEG preparation; all polyps will be resected and documented. Operator allocation to high- (≥200 colonoscopies/year) or low-volume (<200/year) groups will follow routine clinical scheduling, with stratified analyses performed. The trial involves no investigational drugs or additional invasive procedures, and no adverse events are anticipated beyond those inherent to colonoscopy.
- Conditions
- Colorectal Polyps
- Being tested
- Colonoscopy with CADe system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy with CADe systemDevice
Patients in the CADe+ arm underwent colonoscopy with CADe DISCOVERY™ (PENTAX Medical, Tokyo, Japan), an AI-driven tool highlighting suspected lesions in real-time, through a light-blue box. The final lesion characterization remained the endoscopist's responsibility.
| Study group | Role | What they receive |
|---|---|---|
| CADe+ | Experimental | colonoscopy with CADe system Receives: Device: Colonoscopy with CADe system |
| CADe- | No intervention | colonoscopy without CADe system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate
Adenoma detection rate (ADR) is the percentage of patients with at least one histologically proven adenoma or carcinoma
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Aug 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypsStudies 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
- Masking
- None (open label)
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gian Eugenio Tontini
- Sponsor type
- University, hospital or other
- Collaborators
- Pentax Medical
- Responsible party
- Sponsor-investigator, Gian Eugenio Tontini, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Gian Eugenio Tontini, MD, PhD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171333
- Sponsor's protocol ID
- OSMAMI-15/09/2022-0042892-U
- Acronym
- CADEC
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Computer-Aided Detection Colonoscopy in Polyp Detection Rate: an Italian Multi-Center Randomized Study (CADEC)
- ClinicalTrials.gov ID
- NCT07171333
- Acronym / sponsor ID
- CADEC / OSMAMI-15/09/2022-0042892-U
- Conditions
- Colorectal Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- Gian Eugenio TontiniUniversity, hospital or other
- Collaborators
- Pentax Medical
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 12 Sep 2025 (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.
High-definition (HD) colonoscopy is the gold standard for early diagnosis and treatment of lower gastrointestinal neoplasms, with the adenoma detection rate (ADR) serving as a key quality indicator due to its inverse correlation with colorectal cancer incidence. ADR is influenced by operator expertise, fatigue, and human error, which may be mitigated by advanced imaging technologies such as computer-aided detection (CADe). CADe systems provide real-time visual and auditory alerts for suspected polyps and have been shown to increase ADR, though their effectiveness under different operator conditions (high- vs. low-volume, fatigue-related performance, impact on polyp detection rate [PDR] and withdrawal time) remains unclear. This multicenter, prospective, national, open-label randomized trial (6 Italian centers) will compare HD-Iscan colonoscopy with and without CADe assistance (1:1 allocation), with primary endpoint ADR and secondary endpoints including PDR, withdrawal time, and performance stratified by operator fatigue. Eligible patients (aged 40-80, undergoing screening, surveillance, or diagnostic colonoscopy) will be recruited consecutively, with exclusions for prior colonic resection, recent diverticulitis, inflammatory bowel disease, familial polyposis, inadequate bowel preparation, complete colonoscopy within 5 years, inability to consent, or unsafe ongoing antithrombotic therapy. Colonoscopies will follow ESGE guidelines with standard split-dose PEG preparation; all polyps will be resected and documented. Operator allocation to high- (≥200 colonoscopies/year) or low-volume (<200/year) groups will follow routine clinical scheduling, with stratified analyses performed. The trial involves no investigational drugs or additional invasive procedures, and no adverse events are anticipated beyond those inherent to colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CADe+ | Experimental | Device: Colonoscopy with CADe systemcolonoscopy with CADe system |
| CADe- | No intervention | –colonoscopy without CADe system |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 40-80 years, any sex
- Indication for screening, surveillance, or diagnostic colonoscopy (e.g., anemia, abdominal symptoms)
- Written informed consent
Key exclusion criteria (7 listed)
- Previous (even partial) colon resection or colonic stenosis
- Acute diverticulitis within 4 weeks
- Inflammatory bowel disease, familial adenomatous polyposis, or microscopic colitis
- Complete colonoscopy within 5 years
- Inadequate suspension of antithrombotic/antiplatelet therapy (per ESGE guidelines)
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 |
|---|---|---|
| Colonoscopy with CADe systemPatients in the CADe+ arm underwent colonoscopy with CADe DISCOVERY™ (PENTAX Medical, Tokyo, Japan), an AI-driven tool highlighting suspected lesions in real-time, through a light-blue box. The final lesion characterization remained the endoscopist's responsibility. | Device | CADe+ |
Primary outcome
Adenoma Detection Rate
Time frame: 2 weeks
Adenoma detection rate (ADR) is the percentage of patients with at least one histologically proven adenoma or carcinoma
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 12 Sep 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
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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.
Gian Eugenio Tontini, MD, PhD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy with CADe system in people with Colorectal Polyps, run by Gian Eugenio Tontini at 1 site in Italy.
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 7 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 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 (time frame: 2 weeks). 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 12 Sep 2025.