Clinical trial · Interventional
Artificial Intelligence-assisted Colonoscopy in the Detection and Characterization of Colorectal Lesions
Artificial Intelligence-assisted Colonoscopy in the Detection and Characterization of Colorectal Lesions: Randomized Controlled Clinical Trial
NCT07066046CI-TRIAL-00115540recruitingN/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 study aims to evaluate the effectiveness of artificial intelligence-assisted colonoscopy in increasing adenoma detection rate and the accuracy in the characterization of colorectal lesions, compared to standard colonoscopy, in a randomized controlled clinical trial setting.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomatous Polyposis | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Lesions | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Colonoscopy with the aid of artificial intelligence
- description
- Stratum 1: Patients aged 18 to 44 years Stratum 2: Patients aged 45 to 75 years Stratum 3: Patients aged 76 years or older
- interventionNames
- Procedure: Colonoscopy
- type
- ACTIVE_COMPARATOR
- label
- Colonoscopy without the aid of artificial intelligence
- description
- Stratum 1: Patients aged 18 to 44 years Stratum 2: Patients aged 45 to 75 years Stratum 3: Patients aged 76 years or older
- interventionNames
- Procedure: Colonoscopy
Primary outcomes (1)
- measure
- Number of patients with at least one adenoma detected, confirmed by histopathological analysis, during colonoscopy, in the AI group vs. control group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients aged 18 years or older, with an elective indication for colonoscopy who sign the informed consent form agreeing to participate in the study. Exclusion Criteria: * History of inflammatory bowel disease. * History of colorectal cancer. * Personal history of colorectal surgery. * Contraindication to endoscopic biopsies. * History of intestinal polyposis syndromes. * Urgent or emergency cases. * Presence of severe, decompensated comorbidities, or with a score of 3 or higher according to the American Society of Anesthesiologists (ASA) classification. * Incomplete colonoscopy that does not reach the cecum. * Insufficient or inadequate bowel preparation, with a score lower than 6 on the Boston Bowel Preparation Scale. * Patients who do not agree to participate in the study and do not sign the informed consent form (ICF).
References
Publications (0)
Data not yet available
No reference posted for this study.