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Comparison Between HD+ Endoscopy and Standard Videoendoscopy in Screening Colonoscopy

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ClinicalTrials.gov Identifier: NCT00792649
Recruitment Status : Unknown
Verified February 2008 by Johannes Gutenberg University Mainz.
Recruitment status was:  Enrolling by invitation
First Posted : November 18, 2008
Last Update Posted : November 18, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
Colonoscopy is the accepted gold standard for screening of colorectal cancer. However, small and flat neoplastic lesions might be overlooked with standard video endoscopes. The new available EPKi system (Pentax, Japan) enables with HD+ imaging resolution above HDTV standard. Aim of the study was to test the efficacy of HD+ colonoscopy alone and in conjunction with I-Scan (newly developed post processing digital filter)in comparison to standard videoendoscopy

Condition or disease
Polyps Neoplasia

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
1
screening colonoscopy with HD+ endoscopes
2
screening colonoscopy with standardvideoendoscopes


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients scheduled for screening colonoscopy were examined using HD+ colonosccopes and standardendoscopes.
Criteria

Inclusion Criteria:

  • Consecutive patients scheduled for screening colonoscopy

Exclusion Criteria:

  • Inflammatory bowel disease
  • Cancer
  • Pregnancy
  • Inability to obtain informed consent
  • Prothrombin time < 50% of control
  • Partial thromboplastin time > 50 seconds
More Information

Responsible Party: Hoffman Arthur
ClinicalTrials.gov Identifier: NCT00792649     History of Changes
Other Study ID Numbers: 837.386.07
First Posted: November 18, 2008    Key Record Dates
Last Update Posted: November 18, 2008
Last Verified: February 2008