UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025693
Receipt number R000029559
Scientific Title Usefulness and adverse events of double-balloon enteroscopy and small bowel capsule endoscopy in small bowel diseases
Date of disclosure of the study information 2017/01/16
Last modified on 2017/01/16 11:33:02

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Basic information

Public title

Usefulness and adverse events of double-balloon enteroscopy and small bowel capsule endoscopy in small bowel diseases

Acronym

Usefulness of double-balloon enteroscopy and small bowel capsule endoscopy

Scientific Title

Usefulness and adverse events of double-balloon enteroscopy and small bowel capsule endoscopy in small bowel diseases

Scientific Title:Acronym

Usefulness of double-balloon enteroscopy and small bowel capsule endoscopy

Region

Japan


Condition

Condition

Small bowel diseases

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Double-balloon enteroscopy and small bowel capsule endoscopy has been a breakthrough for the diagnosis and treatment of small bowel diseases. In this study, we retrospectively and prospectively analyzed the usefulness and adverse events for various small bowel diseases.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Diagnostic yields of double-balloon enteroscopy and small bowel capsule endoscopy

Key secondary outcomes

Adverse events of double-balloon enteroscopy and small bowel capsule endoscopy
Usefulness of vascular index based on comorbidities
Rebleeding rate
Prognosis


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

0 years-old <=

Age-upper limit

110 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with suspected or documented small bowel diseases

Key exclusion criteria

Patients with severe illness in whom double-balloon enteroscopy is contaraindication.

Target sample size

3000


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

TEL

0562939240

Email

nohmya@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

TEL

0562939240

Homepage URL


Email

nohmya@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

藤田保健衛生大学医学部附属病院(愛知県)


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 16 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

It is now ongoing study.

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

2003 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2003 Year 06 Month 01 Day

Last follow-up date

2030 Year 03 Month 31 Day

Date of closure to data entry

2030 Year 05 Month 31 Day

Date trial data considered complete

2030 Year 05 Month 31 Day

Date analysis concluded

2030 Year 07 Month 31 Day


Other

Other related information

NOne


Management information

Registered date

2017 Year 01 Month 16 Day

Last modified on

2017 Year 01 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029559


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name