Clinical trial · Observational
A Prospective Study to Evaluate the Diagnostic Accuracy of Computer-aided Diagnosis (CADx) System in Real-time Characterization of Colorectal Neoplasia
NCT05414383CI-TRIAL-00073871CADxnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The investigators hypothesize that a newly developed CADx system will have a higher diagnostic accuracy in predicting histopathology of colorectal neoplasia than both expert and junior endoscopists.
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 |
|---|---|---|---|
| CADx | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- CADx
- description
- Histopathology prediction by CADx device
- interventionNames
- Device: CADx
- label
- Endoscopist
- description
- Real-time histopathology prediction by expert and non-expert endoscopists
Primary outcomes (1)
- measure
- Diagnostic accuracy
- timeFrame
- During the colonoscopy
- description
- area under receiver operating characteristic curves, AUROC in prediction of final histopathology
Secondary outcomes (5)
- measure
- Sensitivity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. They have received colonoscopy for screening, surveillance or symptom investigation; 2. They have endoscopic images and videos captured and stored during colonoscopy which are available to be retrieved; 3. They have histologically proven colorectal neoplasia. 4. Written consent obtained Exclusion Criteria: 1. Poor quality endoscopic images and videos defined as: 1. Incomplete visualization of the colorectal neoplasia due to technical reasons (e.g. out-of-focus, motion-blurred or insufficient illumination); 2. Artifacts due to mucus, air bubbles, stool, or blood. 2. Active gastrointestinal bleeding; 3. Fulminant colitis; 4. Obscured view due to poor bowel preparation; 5. Artificial staining of lesion due to chromoendoscopy. 6. Unable to obtain informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.