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Third Eye Retroscope Randomized Clinical Evaluation

NCT01044732 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2017-07-25

Study results available
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Summary

The Third Eye® Retroscope® is a device that can be inserted through the instrument channel of a standard colonoscope to provide an additional, retrograde (or backward) view that reveals areas behind folds and flexures in the colon, and might detect additional polyps that cannot be seen with the colonoscope alone.

Patients who participate as subjects in the study will undergo two complete colonoscopy procedures, a standard colonoscopy and a colonoscopy in which a Third Eye Retroscope is used along with the same colonoscope. Half of the patients will have the standard colonoscopy first followed by the Third Eye colonoscopy, and the other half will have the Third Eye procedure first.

Results from the two groups will be analyzed and compared to determine the effectiveness of the Third Eye Retroscope for detecting additional adenomas and other polyps compared with the standard colonoscope alone.

Conditions

  • Colorectal Neoplasms

Interventions

DEVICE

Third Eye Retroscope

Device used with colonoscope to provide second, retrograde view of the colon

Sponsors & Collaborators

  • Avantis Medical Systems

    lead INDUSTRY

Principal Investigators

  • Peter D. Siersema, MD, PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States
  • Belgium
  • Italy
  • Netherlands
  • United Kingdom

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 NCT01044732 on ClinicalTrials.gov