Comparison of Narrow Band Imaging With or Without Magnifying Colonoscopy

NCT ID: NCT01577875

Last Updated: 2014-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-03-31

Brief Summary

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The aim of this study is to evaluate the usefulness of magnifying colonoscopy with narrow band imaging.

Detailed Description

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The accuracy of histologic prediction for the colorectal polyps with the use of narrow band imaging is evaluated between the test group with magnifying colonoscopy and the control group without magnifying colonoscopy.

Conditions

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Intestinal Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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control group

histologic prediction only with the narrow band imaging (without magnification)

Group Type NO_INTERVENTION

No interventions assigned to this group

test group

histologic prediction with narrow band imaging plus magnification

Group Type OTHER

NBI with magnification

Intervention Type DEVICE

After randomization of the subjects into two groups(1) NBI with magnification, 2) without magnification), one experienced endoscopist records its site, size, shape, and predicted histologic diagnosis on the every polyp observed and endoscopically resected. Two groups will be compared with each other.

Interventions

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NBI with magnification

After randomization of the subjects into two groups(1) NBI with magnification, 2) without magnification), one experienced endoscopist records its site, size, shape, and predicted histologic diagnosis on the every polyp observed and endoscopically resected. Two groups will be compared with each other.

Intervention Type DEVICE

Other Intervention Names

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Narrow band image with magnification

Eligibility Criteria

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Inclusion Criteria

* Subjects with colorectal polyps which are in need of EMR

Exclusion Criteria

* pregnancy, IBD, colorectal cancer, etc.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyoung Sup Hong, MD

Role: PRINCIPAL_INVESTIGATOR

SNUH Internal Medicine

Locations

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SNUH

Jongno-gu, Seoul, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NBI_Zoom_CVS_01

Identifier Type: -

Identifier Source: org_study_id