Clinical trial · Interventional
The Yield of Artificial Intelligence (GI Genius) in Lynch Syndrome - A Randomized Tandem-colonoscopy Trial
NCT06654128CI-TRIAL-00108831completedN/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)
We aim to investigate the incremental detection rate of polyps using AI- assisted colonoscopy compared with high-definition white-light endoscopy (HD-WLE). We will conduct a single-center randomized tandem colonoscopy trial of patients with Lynch syndrome with and without AI. Patients will undergo tandem colonoscopy, the second colonoscopy with either HD-WLE or an AI- assisted device.
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 |
|---|---|---|---|
| Lynch Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| artificial intelligence | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- high-definition white-light endoscopy
- description
- patients undergoing first and second colonoscopy with high-definition white-light endoscopy
- type
- ACTIVE_COMPARATOR
- label
- artificial intelligence
- description
- patients undergoing first colonoscopy with high-definition white-light endoscopy and second colonoscopy with artificial intelligence
- interventionNames
- Diagnostic Test: artificial intelligence
Primary outcomes (1)
- measure
- adenoma incremental detection rate
- timeFrame
- From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients with a known pathogenic variant in one of the mismatch repair genes, who are undergoing endoscopic screening and surveillance in our institute Exclusion Criteria: * patients \< 18 years old * lack of informed consent * concomitant inflammatory bowel disease * previous total colectomy * inadequate bowel cleansing (Boston Bowel Preparation Scale (BBPS) ≤5 or \< 2 in one of the 3 segments)
References
Publications (0)
Data not yet available
No reference posted for this study.