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NCT00792649 Clinical Trial

Comparison Between HD+ Endoscopy and Standard Videoendoscopy in Screening Colonoscopy

Polyps Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT00792649
Other study ID # 837.386.07
Secondary ID
Status Enrolling by invitation
Phase N/A
First received November 17, 2008
Last updated November 17, 2008
Start date February 2008

Study information
Verified date February 2008
Source Johannes Gutenberg University Mainz
Contact n/a
Is FDA regulated No
Health authority Germany: ethical committee of Rheinland-Pfalz, Germany
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 200
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Johannes Gutenberg University Mainz
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