Phase 4
N=284
Clinical Evaluation of Narrow Band Imaging Colonoscope
Colonic Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00628147 ↗Enrolled (actual)
284
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Neoplasm Miss Rate — 12.6; 12.1 Miss rate percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Narrow band imaging colonoscope (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Palo Alto Health Care System
- Primary completion
- Feb 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neoplasm Miss Rate |
12.6; 12.1 | — |
| SECONDARY Neoplasm Detection Rates |
69; 66; 29; 31; 40; 35 | — |
| SECONDARY Completion of Examinations |
135; 141 | — |
| SECONDARY Procedure Complications |
0; 0 | — |
Summary
The purpose of the study is to determine if colonoscopic examination using a colonoscope with a narrow band imaging light is more effective at detecting polyps compared to a colonoscope with standard full spectrum white light.
Eligibility Criteria
Inclusion Criteria
- referred for elective outpatient colonoscopy
Exclusion Criteria
- known inflammatory bowel disease
- personal or family history of polyposis syndrome
- referral for resection of a known lesion
Data sourced from ClinicalTrials.gov (NCT00628147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.