Clinical trial · Interventional
Combination of Artificial Intelligence and Mucosal Exposure Device to Enhance Colorectal Neoplasia Detection
Combination of Artificial Intelligence (ENDOAID) and Mucosal Exposure Device (ENDOCUFF) to Enhance Colorectal Neoplasia Detection: a Randomized Controlled Trial
NCT05414448CI-TRIAL-00109030AIDENcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 investigators hypothesize that the combined use of CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) would improve the adenoma detection rate when compared to CADe system alone.
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 | 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 |
|---|---|---|---|
| ENDOCUFF | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- ENDOAID
- description
- CADe system will be used during withdrawal phase of colonoscopy.
- type
- EXPERIMENTAL
- label
- ENDOAID with ENDOCUFF
- description
- CADe system and mucosal exposure device (ENDOCUFF) will be used during withdrawal phase of colonoscopy.
- interventionNames
- Device: ENDOCUFF
Primary outcomes (1)
- measure
- ADR
- timeFrame
- During the colonoscopy
- description
- adenoma detection rate
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 45-85 years old; 2. They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or altered bowel habit; 3. Written informed consent obtained. Exclusion Criteria: 1. Contraindication to colonoscopy (e.g. intestinal obstruction or perforation) 2. Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets) 3. Staged procedure for polypectomy or biopsy of known unresected lesions 4. Previous surgical resection of colon 5. Personal history of colorectal cancer 6. Personal history of familial polyposis syndrome 7. Personal history of inflammatory bowel disease 8. Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above) 9. Pregnancy 10. Unable to obtain informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.