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Clinical Study of Real Time Colorectal Polyp Diagnosis During Colonoscopy - the VALID Colonoscopy Study

NCT01288833 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 558

Last updated 2018-06-01

Study results available
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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.

Conditions

  • Colorectal Neoplasm
  • Colonic Polyps

Interventions

DEVICE

Close focus HD NBI Colonoscopy System

Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth.

Sponsors & Collaborators

  • Kansas City Veteran Affairs Medical Center

    collaborator FED

  • VA Palo Alto Health Care System

    lead FED

Principal Investigators

  • Tonya Kaltenbach, MD MS · Veterans Affairs Palo Alto

  • Roy Soetikno, MD MS · Veterans Affairs Palo Alto

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2015-06-30
Completion
2015-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01288833 on ClinicalTrials.gov