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NCT04441580: GENIAL-CO
Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in a Screening Setting
NA trial testing CADe colonoscopy using GI Genius device in Colonic Neoplasms in 900 participants. Completed in 31 December 2023.
31 October 2023
Quick facts
| Lead sponsor | Fondazione Poliambulanza Istituto Ospedaliero |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 900 |
| Start date | 4 May 2020 |
| Primary completion | 31 October 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- CADe colonoscopy using GI Genius device
Conditions studied
- Colonic Neoplasms — all drugs for Colonic Neoplasms →
- Colonic Adenocarcinoma — all drugs for Colonic Adenocarcinoma →
- Polyps of Colon — all drugs for Polyps of Colon →
- Rectal Neoplasms — all drugs for Rectal Neoplasms →
Sponsor
Fondazione Poliambulanza Istituto Ospedaliero — full company profile →
Who can join
Adults 50 to 69, any sex, with Colonic Neoplasms or Colonic Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Impact of Artificial Intelligence for Detection of Precancerous Colonic Lesions in a Fecal Immunochemical Blood Test-Based Organized Screening Program in Italy: A Randomized Control Trial.
Spada C, Cesaro P, Fuccio L, Salvi D, et al · · 2026 · cited 2× · PMID 41563802 · DOI 10.1002/ueg2.70176
Verify or expand the search:
- PubMed search for NCT04441580
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04441580 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione Poliambulanza Istituto Ospedaliero
- Last refreshed: 10 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04441580.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing