Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Comparison Between HD+ Endoscopy and Standard Videoendoscopy in Screening Colonoscopy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT00792649
First received: November 17, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  Purpose

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
Polyps
Neoplasia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Johannes Gutenberg University Mainz:

Estimated Enrollment: 200
Study Start Date: February 2008
Groups/Cohorts
1
screening colonoscopy with HD+ endoscopes
2
screening colonoscopy with standardvideoendoscopes

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Hoffman Arthur
ClinicalTrials.gov Identifier: NCT00792649     History of Changes
Other Study ID Numbers: 837.386.07
Study First Received: November 17, 2008
Last Updated: November 17, 2008
Health Authority: Germany: ethical committee of Rheinland-Pfalz, Germany

ClinicalTrials.gov processed this record on November 25, 2014