Clinical trial · Interventional
Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy (COLO-GENIUS)
Impact of Artificial Intelligence Genius® System-assisted Colonoscopy vs. Standard Colonoscopy on Adenoma Detection Rate in Routine Practice: a Prospective Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This controlled-randomized trial compares the artificial intelligence Genius® system assisted (Genius+) to standard (Genius-) colonoscopy. The aim of this study was to evaluate the impact of Genius® system on ADR in routine colonoscopy. The secondary aims will be the impact of Genius® system on polyp detection rate (PDR), serrated polyp detection rate (SPDR), advanced neoplasia detection rate (ANDR), mean number of polyps (MNP), polyp type and localization, and operator type (according to basal ADR).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Artificial Intelligence | — | UNRESOLVED | — |
| Colonic Adenoma | Colon Adenoma | ALIAS | 0.90 |
| Colonic Neoplasms | Colon Neoplasm | ALIAS | 0.90 |
| Colonic Polyp | — | UNRESOLVED | — |
| Colonoscopy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genius® System-assisted Colonoscopy | Other | — | UNRESOLVED |
| Standard Colonoscopy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1- Standard colonoscopy
- description
- Standard colonoscopy is performed
- interventionNames
- Other: Standard Colonoscopy
- type
- ACTIVE_COMPARATOR
- label
- Arm 2- Colonoscopy assisted by Genius
- description
- Colonoscopy assisted by Genius artificial intelligence system is performed
- interventionNames
- Other: Genius® System-assisted Colonoscopy
Primary outcomes (1)
- measure
- Adenoma Detection Rate (ADR)
- timeFrame
- 1 day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient scheduled for total colonoscopic exploration, during the period study * Patient over or equal to 18 years * ASA 1, ASA 2, ASA 3 * No participation in another clinical study * Certificate of non opposition signed Exclusion Criteria: * Patient under 18 years old * ASA 4, ASA 5 * Pregnant woman * Patient with coagulation abnormalities preventing polypectomy: prothrombin level \<50%, Platelets \<50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress. * Patient referred for resection of a known polyp * Inflammatory bowel disease * Known colonic stenosis * Diverticulitis less than 6 weeks old * Patient unable to give consent or protected by law * Opposition expressed for inclusion in the study
References
Publications (1)
- DERIVEDKarsenti D, Tharsis G, Perrot B, Cattan P, Percie du Sert A, Venezia F, Zrihen E, Gillet A, Lab JP, Tordjman G, Cavicchi M. Effect of real-time computer-aided detection of colorectal adenoma in routine colonoscopy (COLO-GENIUS): a single-centre randomised controlled trial. Lancet Gastroenterol Hepatol. 2023 Aug;8(8):726-734. doi: 10.1016/S2468-1253(23)00104-8. Epub 2023 Jun 1. PMID 37269872