Clinical trial · Interventional
G-Eye Advanced Colonoscopy For Increased Polyp Detection Rate-randomized Tandem Study With Different Endoscopist
G-Eye Advanced Colonoscopy For Increased Polyp Detection Rate - Randomized Tandem Study With Different Endoscopist
NCT02066064CI-TRIAL-00020896completedN/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 purpose of this study is to compare the adenoma detection rate of G-EYE™ high definition colonoscopy with that of standard high definition 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 Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| G-EYE(TM) Colonoscopy | Procedure | — | UNRESOLVED |
| Standard Colonoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Subjects will undergo complete standard colonoscopy, followed by G-EYE(TM) Colonoscopy
- interventionNames
- Procedure: Standard Colonoscopy
- Procedure: G-EYE(TM) Colonoscopy
- type
- ACTIVE_COMPARATOR
- label
- Group B
- description
- Subject will undergo G-EYE(TM) colonoscopy followed by standard colonoscopy
- interventionNames
- Procedure: Standard Colonoscopy
- Procedure: G-EYE(TM) Colonoscopy
Primary outcomes (1)
- measure
- G-EYE™ colonoscopy detection rate of adenomas and serrated lesions compared to the standard colonoscopy detection rate of the same.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients over 50 years old 2. Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits or for 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 9. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
References
Publications (0)
Data not yet available
No reference posted for this study.