Clinical trial · Interventional
Artificial Intelligence for Diminutive Polyp Characterization
Efficacy and Cost-effectiveness of an Artificial Intelligence System (GI-Genius) on the Characterization of Diminutive Colorectal Polyps Within a Colorectal Cancer Screening Program: a Multicenter Randomized Controlled Trial (ODDITY 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)
Artificial intelligence is a promising tool that may have a role in characterizing colon epithelial lesions (CADx), helping to get a reliable optical diagnosis regardless of the endoscopist experience. Performances of the different CADx systems are variable but it seems that, in most cases, high accuracy and sensitivities are achieved. However, these CADx systems have been developed and validated using still pictures or videos, and a real-world accurate test is lacking. No clinical trials have tested this technology in clinical practice and, therefore, performance in real colonoscopies, practical problems, applicability, and cost are unknown.
Conditions
Conditions (1)
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 Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GI-Genius artificial intelligence | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Human optical diagnosis (HOD)
- description
- The examinator will provide a HOD for every lesion (regardless of their size) found during the examination (adenoma vs non-adenoma) following one of the available validated classifications (NICE, JNET, BASIC). He/she will also give a level of confidence in his/her diagnosis (high/low confidence). However, only diminutive lesions will be considered when analyzing the main outcome. The time to get a HOD will be recorded. An in situ surveillance interval will be provided if possible.
- type
- EXPERIMENTAL
- label
- Artificial intelligence optical diagnosis (AIOD):
- description
- GI-Genius will provide an artificial intelligence diagnosis (AIOD) for every lesion detected (adenoma vs non-adenoma). Only diminutive lesions will be considered for the analysis of the main outcome. However, data on larger lesions will be recorded to describe GI-Genius´ performance in detail (secondary outcome). The time to get an AIOD will be recorded. An in situ surveillance interval will be provided if possible
- interventionNames
- Device: GI-Genius artificial intelligence
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients attending a colonoscopy within a population-based CRC screening program (FIT- or colonoscopy-based) or because of post-polypectomy surveillance, * Written informed consent before the colonoscopy, Exclusion Criteria: * None, patient included * Previous history of inflammatory bowel disease. * Previous history of CRC * Previous CR resection * Polyposis or hereditary CRC syndrome * Coagulopathy/Anticoagulants * Unwillingness to participate
References
Publications (0)
Data not yet available