Clinical trial · Interventional
Performance Evaluation of the NaviAid™ G-Eye System
NCT01552200CI-TRIAL-00014202completedN/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 additional diagnostic yield obtained by performing NaviAid™ G-Eye procedure vs. the diagnostic yield obtained by performing standard colonoscopy procedure.
Conditions
Conditions (3)
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 |
| Polyp | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group A-Standard Colonoscopy, then NaviAid™ G-Eye procedure | Procedure | — | UNRESOLVED |
| Group B-NaviAid™ G-Eye procedure, then Standard Colonoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A-Standard Colonoscopy, G-Eye procedure
- description
- Standard Colonoscopy,G-Eye procedure
- interventionNames
- Procedure: Group A-Standard Colonoscopy, then NaviAid™ G-Eye procedure
- type
- ACTIVE_COMPARATOR
- label
- B- G-Eye procedure, Standard Colonoscopy
- description
- G-Eye procedure,Standard Colonoscopy
- interventionNames
- Procedure: Group B-NaviAid™ G-Eye procedure, then Standard Colonoscopy
Primary outcomes (1)
- measure
- NaviAid™ G-Eye procedure adenoma detection rate compared to the standard colonoscopy procedure adenoma detection rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup; * The patient is over 40 years old; * The patient must understand and provide written consent for the procedure. Exclusion Criteria: * Subjects with inflammatory bowel disease; * Subjects with a personal history of polyposis syndrome; * Subjects with suspected chronic stricture potentially precluding complete colonoscopy; * Subjects with diverticulitis or toxic megacolon; * Subjects with a history of radiation therapy to abdomen or pelvis; * Pregnant or lactating female subjects; * Subjects who are currently enrolled in another clinical investigation. * Subjects with routine oral or parenteral use of anticoagulants * Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke) * Any patient condition deemed too risky for the study by the investigator
References
Publications (1)
- DERIVEDHalpern Z, Gross SA, Gralnek IM, Shpak B, Pochapin M, Hoffman A, Mizrahi M, Rochberger YS, Moshkowitz M, Santo E, Melhem A, Grinshpon R, Pfefer J, Kiesslich R. Comparison of adenoma detection and miss rates between a novel balloon colonoscope and standard colonoscopy: a randomized tandem study. Endoscopy. 2015 Mar;47(3):238-44. doi: 10.1055/s-0034-1391437. Epub 2015 Feb 17. PMID 25704662