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NCT00765180 Clinical Trial

Comparison of Transparent Retractable Extension Device and Narrow Band Imaging on Colorectal Adenoma Detection

Colorectal Cancer Screening Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00765180
Other study ID # TRE2
Secondary ID
Status Completed
Phase N/A
First received October 1, 2008
Last updated November 17, 2015
Start date January 2007
Est. completion date December 2010

Study information
Verified date November 2015
Source Showa Inan General Hospital
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

The investigators previously reported that colonoscopy with a transparent retractable extension (TRE) device improved the adenoma detection rate without affecting intubation and withdrawal times. On the other hand, colonoscopy using narrow band imaging (NBI) is expected to lead to higher rate s of adenoma detection. The investigators compared the effects of TRE device on colorectal adenoma detection with those of NBI.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 100 Years
Eligibility Exclusion Criteria:

- Age less than 20 years old

- Pregnant

- American Society of Anesthesiologists class III and IV

- Overweight (body weight > 100 kg)

- Allergic to the drugs used or its components (soybeans or eggs)

- Poor bowel preparation

- Previous colorectal surgical resection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• TRE vs. NBI
TRE NBI

Locations
Country Name City State
Japan Showa Inan General hospital Komagane Nagano

Sponsors (1)
Lead Sponsor Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Colorectal adenoma detection rate after colonoscopy No
Secondary Procedure time, complication after colonoscopy Yes
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