UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028264
Receipt number R000032345
Scientific Title Usefulness of capsule endoscopy and double-balloon enteroscopy for small-bowel diseases
Date of disclosure of the study information 2017/07/17
Last modified on 2017/07/17 11:32:43

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Basic information

Public title

Usefulness of capsule endoscopy and double-balloon enteroscopy for small-bowel diseases

Acronym

Capsule endoscopy and double-balloon enteroscopy

Scientific Title

Usefulness of capsule endoscopy and double-balloon enteroscopy for small-bowel diseases

Scientific Title:Acronym

Capsule endoscopy and double-balloon enteroscopy

Region

Japan


Condition

Condition

Small-bowel diseases

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the usefulness and the adverse events of capsule endoscopy and double-balloon enteroscopy retrospectively and prospectively for small-bowel diseases

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Usefulnessof capsule endoscopy and double-balloon enteroscopy

Key secondary outcomes

Adverse events of capsule endoscopy and double-balloon enteroscopy


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with documented or suspected small-bowel diseases

Key exclusion criteria

Patients without indications of double-balloon enteroscopy and capsule endoscopy.

Target sample size

1500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoki Ohmiya

Organization

Fujita Health University

Division name

Department of Gastroenterology

Zip code


Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192

TEL

0562-93-9240

Email

nohmiya@fujita-hu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Naoki Ohmiya

Organization

Fujita Health University

Division name

Department of Gastroenterology

Zip code


Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi 470-1192

TEL

0562-93-9240

Homepage URL


Email

nohmiya@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



Funding Source

Organization

Fujita Health University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nagoya University Graduate School of Medicine, Department of Gastroenterology and Hepatology

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

藤田保健衛生大学病院(愛知県)


Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 17 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

Diagnostic yields of double-balloon enteroscopy and capsule endoscopy

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

2016 Year 03 Month 31 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 31 Day

Last follow-up date

2017 Year 12 Month 31 Day

Date of closure to data entry

2017 Year 12 Month 31 Day

Date trial data considered complete

2018 Year 01 Month 10 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information

Adverse events of double-balloon enteroscopy and capsule endoscopy


Management information

Registered date

2017 Year 07 Month 17 Day

Last modified on

2017 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032345


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name