N/A
N=558
Clinical Study of Real Time Colorectal Polyp Diagnosis During Colonoscopy - the VALID Colonoscopy Study
Colorectal Neoplasm · Colonic Polyps
Bottom Line
View on ClinicalTrials.gov: NCT01288833 ↗Enrolled (actual)
558
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Rate of Accurate High Confidence Polyp Histology Predictions by the Endoscopist in the Two Groups. — 75.3; 63.1 Percent of accurate HC predictions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Close focus HD NBI Colonoscopy System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Palo Alto Health Care System
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Accurate High Confidence Polyp Histology Predictions by the Endoscopist in the Two Groups. |
75.3; 63.1 | — |
| SECONDARY Cost |
241; 0 | — |
| SECONDARY Diagnostic Characteristics |
88.5; 87.0; 98.2; 95.2; 73.9; 75.7 | — |
| SECONDARY Accuracy of Predicted Versus Actual Surveillance Intervals |
259; 259; 277; 281 | — |
| SECONDARY Learning Curve |
94.9; 88.0; 96.7; 95.8 | — |
Summary
The investigators hypothesize that high definition colonoscopy with close focus narrow band imaging features has a high diagnostic accuracy for colorectal polyp histology, and can replace formal pathologic assessment in cases of high diagnostic confidence.
Eligibility Criteria
Inclusion Criteria
- Adult patients referred for routine colonoscopy
Exclusion Criteria
- Known inflammatory bowel disease
- Personal or family history of polyposis or non-polyposis syndrome
- Presentation for emergency endoscopy
- Inability to remove polyp due to coagulopathy or thrombocytopenia
- Inability to provide informed consent
Data sourced from ClinicalTrials.gov (NCT01288833). 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.