Colonic AdenomaGENIAL-CO FUNCT06160466
Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in Follow-up Patients in a Screening Setting
A study testing CADe colonoscopy using GI Genius device and White light in people with Colonic Adenoma and Adenoma, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site in Italy.
Trial summary
The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Colonic Adenoma, Adenoma, Polyp of Colon
- What is being tested?
- CADe colonoscopy using GI Genius device and White light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,156 participants
- Where
- 1 siteItaly
- Study dates
- 16 Dec 2020to 1 May 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 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 50 to 74 undergoing colonoscopy examination following a prior colonsocopy were polyps were found (follow-up) performed in the context of a regional mass-screening program.
Who cannot join
- Patients unwilling or unable to give informed consent.
- Patients reporting use of anti-platelet agents or anticoagulants precluding removal of polyps.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Participants undergoing colonoscopy for follow-up in a screening setting will be randomized in a 1:1 ratio to either receive Computer-Aided Detection (CADe) colonoscopy or a conventional colonoscopy (CC). GI Genius is the AI software that will be used in the present trial and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions (such as polyps and adenomas, including those with flat (non-polypoid) morphology) during standard screening and surveillance endoscopic mucosal evaluations. It is not intended to replace histopathological sampling as a means of diagnosis.Researchers will compare the CADe group and the CC-group to see if CAD-e can increase the ADR significantly.
Read the detailed description
Even if colonoscopy is considered the reference standard for the detection of colonic neoplasia, polyps are still missed. In large administrative cohort or case-control studies, the risk of early post-colonoscopy cancer appeared to be independently predicted by a relatively low polyp/adenoma detection rate. The adenoma detection rate among different endoscopists has been shown to be strictly related with the risk of post-colonoscopy interval cancer. When considering the very high prevalence of advanced neoplasia in the FIT-positive enriched population, the risk of post-colonoscopy interval cancer due to a suboptimal quality of colonoscopy may be substantial. Available evidence justifies therefore the implementation of efforts aimed at improving adenoma detection rate, based on retraining interventions and on the adoption of innovative technologies, designed to enhance the accuracy of the endoscopic examination.Nowadays, Artificial intelligence (AI) is gaining increased attention and investigation, since it seems to improve the quality of medical diagnosis and treatment. In the field of gastrointestinal endoscopy, two potential roles of AI in colonoscopy have been examined so far: automated polyp detection (CADe) and automated polyp histology characterization (CADx). CADe can minimize the probability of missing a polyp during colonoscopy, thereby improving the adenoma detection rate (ADR) and potentially decreasing the incidence of interval cancer. GI Genius is the AI software that will be used in the present trial. The software is developed by Medtronic Inc. (Dublin, Ireland) and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions (such as polyps and adenomas, including those with flat (non-polypoid) morphology) during standard screening and surveillance endoscopic mucosal evaluations. It is not intended to replace histopathological sampling as a means of diagnosis.
The objective of this study was to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC). As the risk of progression is higher for large than for small adenomas the specific contribution of the new technique in reducing the miss rate of large neoplasms represents an important outcome to be assessed in the study. In addition, given the suggested association of a higher miss-rate of serrated and flat lesions with an increased risk of early post-colonoscopy CRC, the benefit of the new technique in reducing the miss rate of these lesions will be assessed.
- Conditions
- Colonic Adenoma, Adenoma, Polyp of Colon
- Being tested
- CADe colonoscopy using GI Genius device, White light
- Keywords
- ADR, CADe, Follow-up
- Medical subject headings
- Adenoma, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CADe colonoscopy using GI Genius deviceDevice
We wanted to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC) in a follow-up pateints in the screening population.
White lightDevice
White light endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Artificial intelligence arm Patients undergoing colonoscopy with artificial intelligence. | Experimental | Patients undergoing colonoscopy with artificial intelligence. Receives: Device: CADe colonoscopy using GI Genius device |
| Conventional Colonoscopy | Active comparator | Standard Colonoscopy with white light Receives: Device: White light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Proportion of patients with at least one histologically confirmed adenoma resected divided by the total number of colonoscopies.
Measured: When available the histological report of polyps removed (up to 3 weeks).
Rate of patients detected with 3 or more adenomas.
The percentage of patients with 3 or more adenomas (serrated adenomas will also be considered in the calculation) in CADe colonoscopy group will be compared with the rate of patients with 3 or more adenomas (including serrated adenomas) in standard colonoscopy group.
Measured: When available the histological report of polyps removed (up to 3 weeks).
Secondary outcomes (8)
Overall adenoma and polyp detection rate, flat adenoma and serrated polyps/adenomas.
The percentage of adenomas, polyps (in general), flat adenoma and serrated polyps/adenoma detected will be recorded and compared between the groups.
Measured: When available the histological report of polyps removed (up to 3 weeks).
Size of lesions detected
The size of lesion detected will be measured in millimiters and compared between the groups.
Measured: Immediately after the procedure.
Rate of neoplasia by colonic site
The percentage of patients with neoplasia of proximal (right colonic segments) or distal (left colonic segments and rectum) site will be assessed and compared between the groups.
Measured: Immediately after the procedure.
Post-colonoscopy surveilance
the time interval, expressed in years, to the next suggested follow-up colonoscopy will be assessed and compared between the groups.
Measured: When available the histological report of polyps removed (up to 3 weeks).
Time of cecal intubation.
The time to reach the cecum will be measured in minutes, recorded and compared between the groups.
Measured: Immediately after the procedure.
Withdrawal and total procedure time.
The time of withdrawal (from cecum to anus) and of the overall colonoscopy (from anus to anus) will be measured in minutes, recorded and compared between the groups.
Measured: Immediately after the procedure.
Learning curve.
The above-mentioned outcomes will be calculated for each endoscopist at 3, 6, 9 and 12 months.
Measured: 3, 6, 9 and 12 months.
Specific contribution of AI
Proportion of patients diagnosed with polyps which were detected only by Artificial intelligence
Measured: Immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start16 Dec 2020
- Primary completion1 Mar 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic AdenomaStudies 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
- 1,156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristiano Spada, Principal investigator, Fondazione Poliambulanza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160466
- Sponsor's protocol ID
- NP4451
- Acronym
- GENIAL-CO FU
- Status last verified
- Feb 2024
- First submitted
- 29 Nov 2023
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in Follow-up Patients in a Screening Setting
- ClinicalTrials.gov ID
- NCT06160466
- Acronym / sponsor ID
- GENIAL-CO FU / NP4451
- Conditions
- Colonic Adenoma, Adenoma, Polyp of Colon
- Keywords
- ADR, CADe, Follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,156 participants (actual)
- Lead sponsor
- Fondazione Poliambulanza Istituto OspedalieroUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 7 Dec 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.
The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Participants undergoing colonoscopy for follow-up in a screening setting will be randomized in a 1:1 ratio to either receive Computer-Aided Detection (CADe) colonoscopy or a conventional colonoscopy (CC). GI Genius is the AI software that will be used in the present trial and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions (such as polyps and adenomas, including those with flat (non-polypoid) morphology) during standard screening and surveillance endoscopic mucosal evaluations. It is not intended to replace histopathological sampling as a means of diagnosis.Researchers will compare the CADe group and the CC-group to see if CAD-e can increase the ADR significantly.
Detailed description
Even if colonoscopy is considered the reference standard for the detection of colonic neoplasia, polyps are still missed. In large administrative cohort or case-control studies, the risk of early post-colonoscopy cancer appeared to be independently predicted by a relatively low polyp/adenoma detection rate. The adenoma detection rate among different endoscopists has been shown to be strictly related with the risk of post-colonoscopy interval cancer. When considering the very high prevalence of advanced neoplasia in the FIT-positive enriched population, the risk of post-colonoscopy interval cancer due to a suboptimal quality of colonoscopy may be substantial. Available evidence justifies therefore the implementation of efforts aimed at improving adenoma detection rate, based on retraining interventions and on the adoption of innovative technologies, designed to enhance the accuracy of the endoscopic examination.Nowadays, Artificial intelligence (AI) is gaining increased attention and investigation, since it seems to improve the quality of medical diagnosis and treatment. In the field of gastrointestinal endoscopy, two potential roles of AI in colonoscopy have been examined so far: automated polyp detection (CADe) and automated polyp histology characterization (CADx). CADe can minimize the probability of missing a polyp during colonoscopy, thereby improving the adenoma detection rate (ADR) and potentially decreasing the incidence of interval cancer. GI Genius is the AI software that will be used in the present trial. The software is developed by Medtronic Inc. (Dublin, Ireland) and is intended to be used as an adjunct to colonic endoscopy procedures to help endoscopists to detect in real time mucosal lesions (such as polyps and adenomas, including those with flat (non-polypoid) morphology) during standard screening and surveillance endoscopic mucosal evaluations. It is not intended to replace histopathological sampling as a means of diagnosis.
The objective of this study was to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC). As the risk of progression is higher for large than for small adenomas the specific contribution of the new technique in reducing the miss rate of large neoplasms represents an important outcome to be assessed in the study. In addition, given the suggested association of a higher miss-rate of serrated and flat lesions with an increased risk of early post-colonoscopy CRC, the benefit of the new technique in reducing the miss rate of these lesions will be assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artificial intelligence arm Patients undergoing colonoscopy with artificial intelligence. | Experimental | Device: CADe colonoscopy using GI Genius devicePatients undergoing colonoscopy with artificial intelligence. |
| Conventional Colonoscopy | Active comparator | Device: White lightStandard Colonoscopy with white light |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 50 to 74 undergoing colonoscopy examination following a prior colonsocopy were polyps were found (follow-up) performed in the context of a regional mass-screening program.
Key exclusion criteria (2 listed)
- Patients unwilling or unable to give informed consent.
- Patients reporting use of anti-platelet agents or anticoagulants precluding removal of polyps.
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 |
|---|---|---|
| CADe colonoscopy using GI Genius deviceWe wanted to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC) in a follow-up pateints in the screening population. | Device | Artificial intelligence arm Patients undergoing colonoscopy with artificial intelligence. |
| White lightWhite light endoscopy | Device | Conventional Colonoscopy |
Primary outcome
Adenoma detection rate
Time frame: When available the histological report of polyps removed (up to 3 weeks).
Proportion of patients with at least one histologically confirmed adenoma resected divided by the total number of colonoscopies.
Rate of patients detected with 3 or more adenomas.
Time frame: When available the histological report of polyps removed (up to 3 weeks).
The percentage of patients with 3 or more adenomas (serrated adenomas will also be considered in the calculation) in CADe colonoscopy group will be compared with the rate of patients with 3 or more adenomas (including serrated adenomas) in standard colonoscopy group.
8 secondary outcomes
Overall adenoma and polyp detection rate, flat adenoma and serrated polyps/adenomas.
Time frame: When available the histological report of polyps removed (up to 3 weeks).
Size of lesions detected
Time frame: Immediately after the procedure.
Rate of neoplasia by colonic site
Time frame: Immediately after the procedure.
Post-colonoscopy surveilance
Time frame: When available the histological report of polyps removed (up to 3 weeks).
Time of cecal intubation.
Time frame: Immediately after the procedure.
Withdrawal and total procedure time.
Time frame: Immediately after the procedure.
Learning curve.
Time frame: 3, 6, 9 and 12 months.
Specific contribution of AI
Time frame: Immediately after the 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 Feb 2026.
- 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.
Cristiano Spada principal investigator
Fondazione Poliambulanza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CADe colonoscopy using GI Genius device and White light in people with Colonic Adenoma and Adenoma, run by Fondazione Poliambulanza Istituto Ospedaliero 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 1 inclusion and 2 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 Feb 2026. 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: When available the histological report of polyps removed (up to 3 weeks).). 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 Feb 2026.