Clinical trial · Interventional
RITUAL Ultivision AI CADe Randomized Controlled Trial
Randomized Clinical Trial of the Ultivision AI Artificial Intelligence System for Colorectal Cancer Screening or Surveillance in Colonoscopy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business decision to discontinue the study. Discontinuation is not related to any patient safety or performance issues.
Summary
Brief summary (as posted)
Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas). Ultivision AI CADe is indicated for white light colonoscopy only.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma Colon | — | UNRESOLVED | — |
| Colon Adenoma | Colon Adenoma | ONTOLOGY_EXACT | 0.98 |
| Polyp of Colon | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultivision AI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ultivision AI colonoscopy (CADe Arm)
- description
- Ultivision AI is used to aid in real-time detection of adenomas.
- interventionNames
- Device: Ultivision AI
- type
- ACTIVE_COMPARATOR
- label
- Standard colonoscopy (Control Arm)
- description
- Patients will undergo standard colonoscopy without AI.
- interventionNames
- Device: Ultivision AI
Primary outcomes (2)
- measure
- Adenoma per Colonoscopy (APC)
- timeFrame
- During the procedure/surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 45 to 75 years; 2. Screening or surveillance colonoscopy. 3. Iinformed consent Exclusion Criteria: 1. Colorectal cancer; 2. Inflammatory bowel disease, including Crohn's disease or ulcerative colitis; 3. Polyposis syndrome including Familial Adenomatous Polyposis, Cowden syndome, Linch syndrome, Peutz-Jeghers syndrome, MUITYH associated polyposis, familial Colorectal Cancer type X; 4. Positive Fecal Immunochemical Test; 5. Use anti-platelet agents or anticoagulants that prevent polyps removal; 6. Colon resection, not including the appendix; 7. Subject is pregnant or lactating.
References
Publications (1)
- RESULTUrban G, Tripathi P, Alkayali T, Mittal M, Jalali F, Karnes W, Baldi P. Deep Learning Localizes and Identifies Polyps in Real Time With 96% Accuracy in Screening Colonoscopy. Gastroenterology. 2018 Oct;155(4):1069-1078.e8. doi: 10.1053/j.gastro.2018.06.037. Epub 2018 Jun 18. PMID 29928897