Comparison of Transparent Retractable Extension Device an... | NCT00765180

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

NCT00765180

Sponsor

Showa Inan General Hospital

Status

Completed

Last Update Posted

Nov 18, 2015Estimated

Enrollment

200Actual

Phase

Not Applicable

Conditions

Colorectal Cancer Screening

Interventions

TRE vs. NBI

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Oct 1, 2008

First Submission Date that Met QC Criteria

Oct 1, 2008

First Posted Date

Oct 2, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2015

Last Update Posted Date

Nov 18, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Akira Horiuchi, Digestive Disease Center, Showa Inan General HospitalPrincipal Investigator

Lead Sponsor

Showa Inan General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
TRE vs. NBI	Device	TRE NBI	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Colorectal adenoma detection rate		after colonoscopy

Secondary Outcomes

Measure	Description	Time Frame
Procedure time, complication		after colonoscopy

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Showa Inan General hospital		Komagane	Nagano	399-4191	Japan