An interventional study of CADe colonoscopy using GI Genius device in Colonic Neoplasms, Colonic Adenocarcinoma and Polyps of Colon, sponsored by Fondazione Poliambulanza Istituto Ospedaliero. Completed at 1 site in Italy. Open to participants aged 50 Years to 69 Years. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by Fondazione Poliambulanza Istituto Ospedaliero · Not applicable, Interventional, and Screening
Among 135 studies in Colonic Neoplasms with a site in Italy — 41 open to participants now, 56 under way, 8 of them phase 3. Colonic Neoplasms · Italy.
Among the 135 studies in Colonic Neoplasms with a site in Italy, this one is the 11th largest by enrollment of the 87 interventional ones that give a count, is one of 11 that started in 2020, is one of 29 with no phase, and was the 61st registered.
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
Browse Colonic Neoplasms studies →41 of the 135 studies in Colonic Neoplasms with a site in Italy are open now. Recruiting first, the newest first:
Solstice Oncology, Inc. · Sites in Italy, United States, Belgium and 3 more countries
Ages 18+
Matteo Clavarezza · Sites in Italy
Ages 70–99
Incyte Corporation · Sites in Italy, United States, Argentina and 19 more countries
Ages 18+
Pfizer · Sites in Italy, United States, Argentina and 14 more countries
Ages 18+
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Sites in Italy
Ages 18+ · Healthy volunteers
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 326 Colonic Neoplasms studies recruiting now, 203 (62%) set no upper age limit and 71 (22%) stop at 75 or younger; 19 take children under 18; 34 take healthy volunteers.
This study: 50 Years to 69 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
135 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 29 · Phase 3 27
First in 1991; this study’s year is marked. 11 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 900 is above the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.
Median enrollment 222 across the 87 interventional studies, 345 across the 44 observational. Of the 58 that completed or were terminated, 9 (16%) have results posted.
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36 of 135 have an industry lead sponsor. The 10 most frequent:
Fondazione Poliambulanza Istituto Ospedaliero is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
Fondazione Poliambulanza Istituto Ospedaliero has 2 studies filed under Colonic Neoplasms — fewer than ten, so there is no comparison to draw.
14 of the studies in Colonic Neoplasms with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06567782GlaxoSmithKlineA Study of Neoadjuvant Dostarlimab Plus Capecitabine Plus Oxaliplatin (CAPEOX) Vs CAPEOX With Previously Untreated T4N0 or Stage III Mismatch Repair Proficient (MMRp)/Microsatellite Stable (MSS) Colon Cancer | 2026-11-23 |
| NCT07153458Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisIdentification of New Non-invasive, Predictive, and Diagnostic Biomarkers for Colorectal Cancer | 2026-12-01 |
| NCT06965335Niguarda HospitalEarly-Onset Colorectal Cancer: An Observational Retrospective and Prospective Multicenter Study | 2026-12-31 |
| NCT05714124IRCCS San RaffaeleLiver Embolization Approaches for Tumor Management | 2026-12-31 |
| NCT05186116Azienda Ospedaliero-Universitaria di ModenaLDLT in Non Resectable Colo-rectal Cancer Liver Metastasis | 2027-01-01 |
Add all 14 to your calendar (.ics) → With an account.
Among the 135 studies in Colonic Neoplasms with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Even if colonoscopy is considered the reference standard for the detection of colonic neoplasia, polyps are still missed. The risk of early post-colonoscopy cancer appeared to be independently predicted by a relatively low polyp/adenoma detection rate. 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. Artificial intelligence 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 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).
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing colonoscopy with artificial intelligence.
Device: CADe colonoscopy using GI Genius device
Patients undergoing colonoscopy with standard colonscopy
Device: CADe colonoscopy using GI Genius device
We wanted to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC) in a FIT-positive screening population.
Rate of advanced adenomas
The percentage of patients with adenomas with high-grade displasia in CADe colonoscopy group will be recorded and compared with the rate of patients with adenomas with high-grade displasia in standard colonoscopy group.
Time frame: 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.
Time frame: When available the histological report of polyps removed (up to 3 weeks).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Immediately after the procedure.
Learning curve.
The above-mentioned outcomes will be calculated for each endoscopist at 3, 6, 9 and 12 months.
Time frame: 3, 6, 9 and 12 months.
Patient experience
Visual Analogue Scale (VAS) (0 minimum to 10 maximum) will be recorded to assess the pain before and after the colonoscopy and results will be compared between the groups.
Time frame: Immediately after the procedure.
Specific contribution of AI
Proportion of patients diagnosed with polyps which were detected only by Artificial intelligence
Time frame: Immediately after the procedure.
Ran from May 2020 to primary completion in Oct 2023, 41 months.
Of 382 non-industry interventional studies with no phase under Colonic Neoplasms, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 55. This study's 41 months is above that.
Counting every sponsor, half of 404 studies reached it within 30 months; a quarter within 16 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Fondazione Poliambulanza Istituto Ospedaliero