NCT00765180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

3.9 years

First QC Date

October 1, 2008

Last Update Submit

November 17, 2015

Conditions

Colorectal Cancer Screening

Keywords

colonoscopyhoodNBI

Outcome Measures

Primary Outcomes (1)

  • Colorectal adenoma detection rate

    after colonoscopy

Secondary Outcomes (1)

  • Procedure time, complication

    after colonoscopy

Study Arms (2)

2

ACTIVE COMPARATOR

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

Device: TRE vs. NBI

1

EXPERIMENTAL

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

Device: TRE vs. NBI

Interventions

TRE vs. NBIDEVICE

TRE NBI

12

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Showa Inan General hospital

Komagane, Nagano, 399-4191, Japan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Digestive Disease Center

Study Record Dates

First Submitted

October 1, 2008

First Posted

October 2, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

JP(1)