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NCT04884581: CHANGE
Characterization of Colorectal Neoplasia
NA trial testing GI Genius CADx device in Colonic Polyp in 165 participants. Completed in 5 August 2021.
1 July 2021
Quick facts
| Lead sponsor | Nuovo Regina Margherita Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 165 |
| Start date | 12 May 2021 |
| Primary completion | 1 July 2021 |
| Estimated completion | 5 August 2021 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- GI Genius CADx device
Conditions studied
- Colonic Polyp — all drugs for Colonic Polyp →
Sponsor
Nuovo Regina Margherita Hospital
Who can join
40 and older, any sex, with Colonic Polyp. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a post-marketing, single-arm, prospective study investigating the use of GI Genius CADx device in the real-time characterization of colorectal polyps (i.e. prediction of their histology during the colonoscopy). Patients enrolled will undergo a standard white-light colonoscopy with the support of the latest version of the CE-marked GI Genius CADx device. Colonoscopy will be performed according to the standard practice.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Artificial Intelligence Allows Leaving-In-Situ Colorectal Polyps.
Hassan C, Balsamo G, Lorenzetti R, Zullo A, et al · · 2022 · cited 72× · PMID 35835342 · DOI 10.1016/j.cgh.2022.04.045 -
A novel AI device for real-time optical characterization of colorectal polyps.
Biffi C, Salvagnini P, Dinh NN, Hassan C, et al · · 2022 · cited 28× · PMID 35773468 · DOI 10.1038/s41746-022-00633-6 -
REAL-Colon: A dataset for developing real-world AI applications in colonoscopy.
Biffi C, Antonelli G, Bernhofer S, Hassan C, et al · · 2024 · cited 12× · PMID 38796533 · DOI 10.1038/s41597-024-03359-0
Verify or expand the search:
- PubMed search for NCT04884581
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Colonic Polyp
Currently open trials in the same condition.
- NCT06550908 — Training Physicians to Differentiate the Paris Classification Using Artificial Colon Polyp Images · NA · recruiting
- NCT07456111 — A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy · Phase 4 · recruiting
- NCT06483503 — Extra Wide Field of View Lens Study · active not recruiting
- NCT06077435 — Comparative Analysis of AI Software for Enhanced Polyp Detection and Diagnosis · NA · recruiting
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 NCT04884581 (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 Nuovo Regina Margherita Hospital
- Last refreshed: 6 August 2021
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/NCT04884581.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing