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NCT01288833 · ClinicalTrials.gov registry record · NA
Clinical Study of Real Time Colorectal Polyp Diagnosis During Colonoscopy - the VALID Colonoscopy Study
A NA study of Colonic Polyps and Colorectal Neoplasm, sponsored by VA Palo Alto Health Care System.
- Completed
- Registry status
- NA
- Development phase
- 558
- Enrollment target
- 2
- Study locations
NCT01288833: Completed NA study of Colonic Polyps and Colorectal Neoplasm, sponsored by VA Palo Alto Health Care System.
NCT01288833 is a NA study of Colonic Polyps and Colorectal Neoplasm that has completed, run by VA Palo Alto Health Care System. The registered enrollment target is 558 participants, below the 697-participant average among 6 other Colonic Polyps trials with a reported enrollment target (20% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01288833, a NA study of Colonic Polyps and Colorectal Neoplasm, has completed, sponsored by VA Palo Alto Health Care System.
- COMPLETED
- Registry status
- NA
- Development phase
- 558 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Measure of the percentage of accurate high confidence predictions by the endoscopist in the differentiation of neoplastic from non-neoplastic colorectal lesions, using the high definition NBI colonoscopy with and without close focus features. High confidence was assigned if the polyp had one or more features of Type 2 (neoplasia) or Type 1 (nonneoplasia) in the NICE classification and no features associated with the other histology Note: one patient may have multiple polyps.
Conditions Studied
Interventions
- DEVICE Close focus HD NBI Colonoscopy System
Study Locations (2)
California
- Veterans Affairs Palo Alto - Palo Alto
Missouri
- Veterans Affairs Kansas City - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 558 participants |
| Start Date | 2011-03 |
| Est. Completion | 2015-10 |
| Phase | NA |
What the finished NCT01288833 record still lists
NCT01288833 is an interventional study that assigns participants to a tested intervention. The registered 558 participants enrollment target is mid-sized for trials with a published cap, below the 697-participant average among 6 other Colonic Polyps trials with a reported enrollment target (20% lower).
The record links to 2 conditions, with Colonic Polyps appearing as the primary indexed condition, and to 1 intervention - of which Close focus HD NBI Colonoscopy System is the first listed.
NCT01288833 reports a single indexed study location in California, Missouri.
Frequently Asked Questions
What is clinical trial NCT01288833 about?
NCT01288833 is a clinical study titled "Clinical Study of Real Time Colorectal Polyp Diagnosis During Colonoscopy - the VALID Colonoscopy Study". 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.
What is the current status of trial NCT01288833?
This trial is currently completed. It is a NA study. The enrollment target is 558 participants. The study started on 2011-03. Estimated completion is 2015-10.
What conditions does trial NCT01288833 study?
This clinical trial studies the following conditions: Colonic Polyps, Colorectal Neoplasm.
What interventions are being tested in trial NCT01288833?
The interventions under investigation include: Close focus HD NBI Colonoscopy System (DEVICE).
Who is sponsoring clinical trial NCT01288833?
This trial is sponsored by VA Palo Alto Health Care System, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01288833 being conducted?
This trial has 2 study locations across California, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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