Clinical trial · Interventional
Comparison of Adenoma Detection Rate With ENDOCUFF VISION® vs. G-EYE®
A Prospective Randomized Comparison of Colonoscopy Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®) (Endocuff) Versus a Permanently Mounted Balloon (G-EYE®)
NCT04708951CI-TRIAL-00054608completedN/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 is intended to compare the detection rate obtained by performing G-EYE® high definition colonoscopy vs. the detection rate obtained by performing ECV 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 |
|---|---|---|---|
| ENDOCUFF VISION® device | Device | — | UNRESOLVED |
| G-EYE® colonoscope | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ECV colonoscopy
- description
- EndoCuff Vision® device (ECV)
- interventionNames
- Device: ENDOCUFF VISION® device
- type
- EXPERIMENTAL
- label
- G-EYE® colonoscopy
- description
- G-EYE® colonoscope (G-EYE)
- interventionNames
- Device: G-EYE® colonoscope
Primary outcomes (1)
- measure
- Comparison between adenoma detection rate of G-EYE® colonoscopy and EndoCuff Vision®
- timeFrame
- June 2021
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Screening and surveillance population for Adenoma and CRC. 2. The patient must understand and sign a written informed consent for the procedure. Exclusion Criteria: 1. Subjects with inflammatory bowel disease; 2. Subjects with a personal history of hereditary polyposis syndrome; 3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy; 4. Subjects with diverticulitis or toxic megacolon; 5. Subjects with prior colonic surgery (exclusion appendectomy) 6. Subjects with a history of radiation therapy to abdomen or pelvis; 7. Pregnant or lactating female subjects; 8. Subjects who are currently enrolled in another clinical investigation. 9. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator. 10. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke) 11. Any patient condition deemed too risky for the study by the investigator
References
Publications (0)
Data not yet available
No reference posted for this study.