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NCT04107376 Clinical Trial

Inspection of the Colon Using a Retrograde Viewing Device for Detection of Colorectal Polyps

Adenoma Clinical Trial

Official title:
Inspection of the Colon Using a Retrograde Viewing Device for Detection of Colorectal Polyps

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04107376
Other study ID # Ludwig Demling Endoscopy
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date September 30, 2019

Study information
Verified date September 2019
Source University of Erlangen-Nürnberg Medical School
Contact Timo Rath, MD
Phone +49 9131 85 35000
Email timo.rath@uk-erlangen.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

During standard colonoscopy a substantial number of colorectal polyps may be missed. Previous studies have found a 12-28% of miss rate for all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas. In this study it is tested whether a retro viewing endoscope can detect more colorectal polyps in comparisson to standard forward viewing endoscopy. Further, ppolyps detected, mean adenomas per Patient and withdrawal time are recorded.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date September 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- screening colonoscopy

- 18 years of age

Exclusion Criteria:

- inflammatory bowel disease

- inadequate bowel preparation

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Retroviewing endoscopy
The colon is inspected with a new retroviewing endoscope

Locations
Country Name City State
Germany University Hospital Erlangen Erlangen

Sponsors (1)
Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adenoma detection rate calculation of the adenoma detection rate in each arm 8 months
Secondary Polyp detection rate polyp detection rate in each arm 8 months
Secondary Mean number of adenomas per patient Mean number of adenomas per patient in each arm 8 months
Secondary Withdrawal time Withdrawal time in each arm 8 months
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