UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007746
Receipt number R000009122
Scientific Title Grading of reflux esophagitis by using narrow-band imaging endoscopy: a prospective study
Date of disclosure of the study information 2012/04/13
Last modified on 2015/04/02 09:17:29

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Basic information

Public title

Grading of reflux esophagitis by using narrow-band imaging endoscopy: a prospective study

Acronym

Grading of reflux esophagitis by using narrow-band imaging endoscopy

Scientific Title

Grading of reflux esophagitis by using narrow-band imaging endoscopy: a prospective study

Scientific Title:Acronym

Grading of reflux esophagitis by using narrow-band imaging endoscopy

Region

Japan


Condition

Condition

Reflux esophagitis

Classification by specialty

Gastroenterology Gastrointestinal surgery Laboratory medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study was to compare the endoscopic findings between normal and narrow-band imaging technique for grading of reflux esophagitis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Diagnostic performance for grading of reflux esophagitis

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Investigator diagnose by endoscopy without NBI imaging.

Interventions/Control_2

Investigator diagnose by endoscopy with NBI imaging.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) age 20-85 years

Key exclusion criteria

(1) Any patients judged to be unfit to participate in the study, by the investigator

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruhiro Inoue, MD, PhD

Organization

Showa University Koto Toyosu Hospital

Division name

Digestive Disease Center

Zip code


Address

5-1-38 Toyosu, Koto-ku, Tokyo 135-8577, Japan

TEL

03-6204-6000

Email

haruinoue777@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Haruhiro Inoue, MD, PhD

Organization

Showa University Koto Toyosu Hospital

Division name

Digestive Disease Center

Zip code


Address

5-1-38 Toyosu, Koto-ku, Tokyo 135-8577, Japan

TEL

03-6204-6000

Homepage URL


Email

haruinoue777@yahoo.co.jp


Sponsor or person

Institute

Digestive Disease Center, Showa University Koto Toyosu Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2012 Year 04 Month 13 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2012 Year 04 Month 12 Day

Date of IRB


Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 04 Month 13 Day

Last modified on

2015 Year 04 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009122


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name