search
Back to results

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

Primary Purpose

Colorectal Cancer Screening

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
TRE vs. NBI
Sponsored by
Showa Inan General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer Screening focused on measuring colonoscopy, hood, NBI

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Showa Inan General hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

2

1

Arm Description

The investigators evaluate beneficial effect of colonoscopy using narrow band imaging (NBI) for colorectal adenoma detection.

The investigators evaluate the beneficial effect of colonoscopy with a transparent retractable extension (TRE) device on colorectal adenoma detection rate.

Outcomes

Primary Outcome Measures

Colorectal adenoma detection rate

Secondary Outcome Measures

Procedure time, complication

Full Information

First Posted
October 1, 2008
Last Updated
November 17, 2015
Sponsor
Showa Inan General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00765180
Brief Title
Comparison of Transparent Retractable Extension Device and Narrow Band Imaging on Colorectal Adenoma Detection
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Showa Inan General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening
Keywords
colonoscopy, hood, NBI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Description
The investigators evaluate beneficial effect of colonoscopy using narrow band imaging (NBI) for colorectal adenoma detection.
Arm Title
1
Arm Type
Experimental
Arm Description
The investigators evaluate the beneficial effect of colonoscopy with a transparent retractable extension (TRE) device on colorectal adenoma detection rate.
Intervention Type
Device
Intervention Name(s)
TRE vs. NBI
Intervention Description
TRE NBI
Primary Outcome Measure Information:
Title
Colorectal adenoma detection rate
Time Frame
after colonoscopy
Secondary Outcome Measure Information:
Title
Procedure time, complication
Time Frame
after colonoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Showa Inan General hospital
City
Komagane
State/Province
Nagano
ZIP/Postal Code
399-4191
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs