Clinical trial · Interventional
Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy
Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy: Prospective, Randomized Clinical Performance Evaluation
- 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 is a prospective, multicenter, randomized study to evaluate the clinical performance of a novel CADe device, WISE VISION® Endoscopy System, in patients undergoing high-definition white light (HDWL) colonoscopy for screening or surveillance of colorectal Cancer (CRC). Eligible subjects who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to undergo colonoscopy : * Experimental: CADe colonoscopy procedure with WISE VISION® Endoscopy (CADe Group) * Control: Standard Colonoscopy without CADe (Standard Colonoscopy Group)
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 | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Polyp of Colon | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computer Aided Detection (CADe) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CADe Colonoscopy
- description
- CADe Colonoscopy: Patient undergoes WISE VISION® Endoscopy CADe colonoscopy
- interventionNames
- Diagnostic Test: Computer Aided Detection (CADe)
- type
- ACTIVE_COMPARATOR
- label
- HDWL Colonoscopy
- description
- HDWL Colonoscopy: Patient undergoes HDWL colonoscopy without CADe
- interventionNames
- Diagnostic Test: Computer Aided Detection (CADe)
Primary outcomes (1)
- measure
- Adenomas 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: * Patient is presenting to the endoscopy unit for colon cancer screening or surveillance colonoscopy. * Signed Informed Consent Exclusion Criteria: 1. Contraindications to colonoscopy 2. Colonoscopy within the previous three (3) years 3. High-risk indications for colonoscopy 4. Antithrombotic therapy that cannot be stopped, precluding polyp resection 5. Inflammatory bowel disease 6. Referred for endoscopic mucosal resection (EMR) 7. Familial adenomatous polyposis syndrome or Serrated Polyposis Syndrome 8. Pregnant or planning a pregnancy during the study period
References
Publications (1)
- BACKGROUNDYamada M, Saito Y, Imaoka H, Saiko M, Yamada S, Kondo H, Takamaru H, Sakamoto T, Sese J, Kuchiba A, Shibata T, Hamamoto R. Development of a real-time endoscopic image diagnosis support system using deep learning technology in colonoscopy. Sci Rep. 2019 Oct 8;9(1):14465. doi: 10.1038/s41598-019-50567-5. PMID 31594962