Clinical trial · Interventional
Accuracy of Real Time Characterization in Artificial Intelligence-assisted Colonoscopy
Accuracy of Real Time Characterization in Artificial Intelligence-assisted Colonoscopy - A Prospective Quality Assurance Study
- 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)
The goal of this substudy is to investigate the accuracy of a computer-aided polyp characterization (CADx) system. The main question\[s\] it aims to answer are: • How high is the specificity of the AI system when characterizing colorectal polyps Participants will receive a standard colonoscopy, assisted by the artificial intelligence (AI) assisted system GI Genius. Researchers will compare the AI system´s characterization with the histopathology to see how accurate the system is.
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 |
|---|---|---|---|
| Colorectal Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-assisted colonoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- AI-assisted colonoscopy
- description
- The patients in the intervention group will receive an AI-assisted colonoscopy (AIC) using the computer-aided polyp detection and characterization (CADe and CADx) GI Genius (Medtronic).
- interventionNames
- Device: AI-assisted colonoscopy
Primary outcomes (4)
- measure
- True positive findings: Adenomas (histopathologically verified) characterized as adenomas by the AI system
- timeFrame
- 5 Months
- description
- Data from the AI system will be compared with the histopathological data for each removed polyp
- measure
- True negative findings: Non-adenomas (histopathologically verified) characterized as non-adenomas by the AI system
- timeFrame
- 5 Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Referred for screening colonoscopy due to a positive faecal immunochemical test (FIT) or for * Diagnostic colonoscopy due to symptoms/signs or * Post-polypectomy surveillance colonoscopy (only patients who had all detected polyps removed in the previous colonoscopy) Exclusion Criteria: * Referral for removal of previous detected polyps * Emergency colonoscopy * Control colonoscopy due to inflammatory bowel disease (IBD)
References
Publications (0)
Data not yet available