Clinical trial · Interventional
A Prospective Randomized Study Comparing the Adenoma Detection Yield of SC, AI and Combined AI and G-EYE®
A Prospective Randomized Study Comparing the Adenoma Detection Yield of (i) Standard Colonoscopy ("SC"), (ii) Artificial Intelligence (GI Genius™) ("AI"), and (Iii) Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy
- 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 multicenter, 3-arm, randomized, open-label study. Subjects referred to colonoscopy for screening or surveillance will be randomized in a 2:5:5 into one of the following arms: (i) Standard Colonoscopy (ii) Artificial Intelligence Aided Colonoscopy (GI Genius™) (iii) Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy
Conditions
Conditions (2)
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 (Colon or Rectal) Cancer | Childhood Colorectal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artificial Intelligence Aided Colonoscopy (GI Genius™) | Device | — | UNRESOLVED |
| Combined Artificial Intelligence Aided Colonoscopy (GI Genius™) and G-EYE® Balloon Aided Colonoscopy | Device | — | UNRESOLVED |
| Standard Colonoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Standard Colonoscopy ("SC")
- description
- Subjects enrolled to arm 1 ("SC") will undergo colonoscopy using a standard colonoscope.
- interventionNames
- Device: Standard Colonoscopy
- type
- ACTIVE_COMPARATOR
- label
- Artificial Intelligence Aided Colonoscopy (GI Genius™) ("AI")
- description
- Subjects enrolled to arm 2 ("AI") will undergo colonoscopy using a standard colonoscope aided by Artificial Intelligence (GI Genius™)
- interventionNames
- Device: Artificial Intelligence Aided Colonoscopy (GI Genius™)
- type
- EXPERIMENTAL
- label
- Combined Artificial Intelligence (GI Genius™) and G-EYE® Colonoscopy (AG)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients of age ≥ 45 years old 2. Referred to colonoscopy for screening or surveillance colonoscopy (history of adenoma resection) 3. The patient must understand and provide written consent for the procedure. Exclusion Criteria: 1. Subjects with inflammatory bowel disease 2. Subjects with a personal history of polyposis syndrome 3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy 4. Subjects with diverticulitis or toxic megacolon 5. Subjects with a history of radiation therapy to abdomen or pelvis 6. Pregnant or lactating female subjects 7. Subjects who are currently enrolled in another clinical investigation. 8. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator. 9. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke) 10. Any patient condition deemed too risky for the study by the investigator 11. Previous colonic surgery (except for appendectomy)
References
Publications (0)
Data not yet available