Clinical trial · Interventional
Safety and Efficacy of the NaviAid™ G-Eye System During Colonoscopy
NCT01749722CI-TRIAL-00011504completedN/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)
To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NaviAid™ G-Eye procedure | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NaviAid™ G-Eye procedure
- description
- NaviAid™ G-Eye procedure
- interventionNames
- Device: NaviAid™ G-Eye procedure
Primary outcomes (1)
- measure
- Number of adverse events
- timeFrame
- Subjects will be followed during the study period (approximatly 3 hours) and follow up will be done within 48-72 hours following the procedure
- description
- To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * The patient is undergoing colonoscopy for screening, for surveillance of previous colon polyp(s) or for diagnostic evaluation. * The patient is 40-75 years old; * The patient must understand and provide written informed consent for the procedure. Exclusion Criteria: * Subjects with inflammatory bowel disease; * Subjects with a personal history of polyposis syndrome; * Subjects with suspected colonic stricture potentially precluding complete colonoscopy; * Subjects with active 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)
- DERIVEDGralnek IM, Suissa A, Domanov S. Safety and efficacy of a novel balloon colonoscope: a prospective cohort study. Endoscopy. 2014 Oct;46(10):883-7. doi: 10.1055/s-0034-1377968. Epub 2014 Sep 16. PMID 25225962